Orthofix SRL
Lewisville, TX, US
ORTHOFIX SRL appears in FDA device records in Lewisville, TX. FDA records list 102 510(k) clearances between and , 64 PMA records and 2 registered establishments. As of , FDA records show 88 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Orthofix SRL carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Orthofix US, LLCregistration, 510(k), PMA, enforcement report, recall
510(k) clearance history
Showing 50 of 102FDA records hold 102 510(k) clearances for Orthofix SRL between 1995 and 2026. The busiest year on record is 2017, with 10. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 1 |
| 1996 | 2 |
| 1997 | 2 |
| 1998 | 1 |
| 2003 | 1 |
| 2004 | 1 |
| 2005 | 2 |
| 2006 | 1 |
| 2010 | 4 |
| 2011 | 3 |
| 2012 | 6 |
| 2013 | 3 |
| 2014 | 9 |
| 2015 | 7 |
| 2016 | 7 |
| 2017 | 10 |
| 2018 | 8 |
| 2019 | 3 |
| 2020 | 10 |
| 2021 | 7 |
| 2022 | 3 |
| 2023 | 1 |
| 2024 | 6 |
| 2025 | 2 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260146 | FITBONE® TRANSPORT AND LENGTHENING SYSTEM | HSB | Substantially Equivalent | |
| K253991 | Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA | HSB | Substantially Equivalent | |
| K252088 | Firebird SI Navigation System | OLO | Substantially Equivalent | |
| K250112 | FitboneTM Trochanteric | HSB | Substantially Equivalent | |
| K242270 | OrthoNext Platform System | QIH | Substantially Equivalent | |
| K242861 | TrueLok Elevate | KTT | Substantially Equivalent | |
| K233867 | Fitbone Trochanteric | HSB | Substantially Equivalent | |
| K240749 | PILLAR SA Ti Spacer System (82-XXX) | MAX | Substantially Equivalent | |
| K232648 | RODEO Telescopic Nail | HSB | Substantially Equivalent | |
| K232169 | FITBONE® Transport and Lengthening System | HSB | Substantially Equivalent | |
| K230252 | OFIX MIS App | LLZ | Substantially Equivalent | |
| K211712 | 3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System | KWQ | Substantially Equivalent | |
| K213572 | JuniOrtho Plating System™ | HWC | Substantially Equivalent | |
| K213951 | FORZA XP Expandable Spacer System | MAX | Substantially Equivalent | |
| K212044 | TrueLok Evo | KTT | Substantially Equivalent | |
| K211704 | CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer System, FORZA PEEK Spacer System, FORZA PTC Spacer System, FORZA Ti Spacer System, FORZA XP Expandable Spacer System, Lonestar Cervical Standalone System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, PILLAR SA PTC Spacer System, SKYHAWK Lateral Interbody Fusion System | ODP | Substantially Equivalent | |
| K211710 | Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws), Connector System, FIREBIRD SI Fusion System | NKG | Substantially Equivalent | |
| K210157 | SOLE Medial Column Fusion Plate | HRS | Substantially Equivalent | |
| K210667 | FIREBIRD SI Fusion System | OUR | Substantially Equivalent | |
| K203342 | CONSTRUX Mini Ti Spacer System | ODP | Substantially Equivalent | |
| K203576 | FORZA Ti Spacer System | MAX | Substantially Equivalent | |
| K203138 | FIREBIRD SI Fusion System | OUR | Substantially Equivalent | |
| K202949 | CONSTRUX Mini PEEK Spacer System | ODP | Substantially Equivalent | |
| K202519 | OrthoNext Platform System | LLZ | Substantially Equivalent | |
| K202666 | CONSTRUX Mini PTC Spacer System | ODP | Substantially Equivalent | |
| K201664 | FIREBIRD SI Fusion System | OUR | Substantially Equivalent | |
| K201481 | Centurion POCT System | NKG | Substantially Equivalent | |
| K200246 | JPS JuniOrtho Plating System | HRS | Substantially Equivalent | |
| K200606 | O-Genesis Graft Delivery System | FMF | Substantially Equivalent | |
| K200052 | CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer System | ODP | Substantially Equivalent | |
| K200696 | FIREBIRD SI Fusion System | OUR | Substantially Equivalent | |
| K190388 | RIVAL View Plating Systems and Reduce Fracture Plating Systems | HRS | Substantially Equivalent | |
| K190751 | Connector System | NKG | Substantially Equivalent | |
| K183342 | SambaScrew 3D SI Fusion System | OUR | Substantially Equivalent | |
| K180179 | Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird® NXG Spinal Fixation System; Phoenix® Minimally Invasive Spinal Fixation System; Phoenix® CDX™ Minimally Invasive Spinal Fixation System; JANUS® Midline Fixation Screw; JANUS® Fenestrated Screw | NKB | Substantially Equivalent | |
| K180624 | Guided Growth Plate System Plus | OBT | Substantially Equivalent | |
| K172699 | Agile Nail | HSB | Substantially Equivalent | |
| K172115 | Navigated Instrument System | OLO | Substantially Equivalent | |
| K172698 | G-Beam Fusion Beaming System | HWC | Substantially Equivalent | |
| K180025 | Centurion POCT System | NKG | Substantially Equivalent | |
| K172696 | FORZA® XP Expandable Spacer System | MAX | Substantially Equivalent | |
| K172183 | Guided Growth Plate System Plus | OBT | Substantially Equivalent | |
| K173458 | ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System | HSB | Substantially Equivalent | |
| K173051 | Orthofix MJ-FLEX THE NEW METAIZEAU NAIL | HTY | Substantially Equivalent | |
| K172437 | CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer System | ODP | Substantially Equivalent | |
| K170146 | Galaxy UNYCO System | KTT | Substantially Equivalent | |
| K172194 | Connector System | NKG | Substantially Equivalent | |
| K170647 | Connector System | NKG | Substantially Equivalent | |
| K170650 | Orthofix TrueLok Hexapod System (TL-HEX) V2.0 | KTT | Substantially Equivalent | |
| K171082 | Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation System | NKB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9680825 | 3002807827 | ORTHOFIX SRL | VIA DELLE NAZIONI 9, BUSSOLENGO Verona 37012 IT | 2026 | and 24 more, listed in full below |
| 2183449 | 2183449 | ORTHOFIX US LLC | 3451 Plano Parkway, Lewisville, TX 75056 US | 2026 | and 85 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HSTApparatus, Traction, Non-Powered
- GEFApplier, Staple, Surgical,
- HRXArthroscope
- HWJAwl
- HXWBender
- HTWBit, Drill
- HTQBroach
- HTTBurr, Orthopedic
- GEACannula, Surgical, General & Plastic Surgery
- FZOChisel, Surgical, Manual
- HXDClamp
- HXQCrimper, Pin
- FZSCurette, Surgical, General Use
- FZTCutter, Surgical
- GDIDissector, Surgical, General & Plastic Surgery
- HWRDriver, Prosthesis
- GEGElevator, Surgical, General & Plastic Surgery
- HWBExtractor
- HTDForceps
- HXEFork
- HTJGauge, Depth
- GDHGouge, Surgical, General & Plastic Surgery
- FZXGuide, Surgical, Instrument
- FZYHammer, Surgical
- GDZHandle, Scalpel
- GDGHook, Surgical, General & Plastic Surgery
- HWAImpactor
- HWNInstrument, Compression
- HAOInstrument, Surgical, Non-Powered
- HXLMallet
- GFJMallet, Surgical, General & Plastic Surgery
- FWZOperating Room Accessories Table Tray
- HWMOsteotome
- HWQPasser
- HXIPasser, Wire, Orthopedic
- HTYPin, Fixation, Smooth
- HRSPlate, Fixation, Bone
- HTCPliers, Surgical
- HXBProbe
- HXOPusher, Socket
- HTRRasp
- HTOReamer
- GCZRetainer, Surgical
- GADRetractor
- HSBRod, Fixation, Intramedullary And Accessories
- HTXRongeur
- HRRScissors, Orthopedic, Surgical
- HWCScrew, Fixation, Bone
- HXXScrewdriver
- HXRSpatula, Orthopedic
- GDWStaple, Implantable
- GAHStylet, Surgical, General & Plastic Surgery
- FMFSyringe, Piston
- HXGTamp
- HWXTap, Bone
- FTYTape, Measuring, Rulers And Calipers
- HWTTemplate
- FSMTray, Surgical, Instrument
- HWKTrephine
- HXCWrench
Recall records
Showing 25 of 88| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2732-2026 | Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device | Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111 | Class II | Open, Classified | |
| Z-2731-2026 | Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device | Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111 | Class II | Open, Classified | |
| Z-2730-2026 | Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation device | Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111 | Class II | Open, Classified | |
| Z-2729-2026 | Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device | Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111 | Class II | Open, Classified | |
| Z-0896-2026 | Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer System Model/Catalog Number: 37-6005SP 12mm W X 12mm L, 5mm H, 5 Lordotic 37-6005SP 12mm W X 12mm L, 5mm H, 5 Lordotic 37-6005SP 12mm W X 12mm L, 5mm H, 5 Lordotic 37-6006SP 12mm W X 12mm L, 6mm H, 5 Lordotic 37-6006SP 12mm W X 12mm L, 6mm H, 5 Lordotic 37-6006SP 12mm W X 12mm L, 6mm H, 5 Lordotic 37-6007SP 12mm W X 12mm L, 7mm H, 5 Lordotic 37-6007SP 12mm W X 12mm L, 7mm H, 5 Lordotic 37-6007SP 12mm W X 12mm L, 7mm H, 5 Lordotic 37-6008SP 12mm W X 12mm L, 8mm H, 5 Lordotic 37-6008SP 12mm W X 12mm L, 8mm H, 5 Lordotic 37-6008SP 12mm W X 12mm L, 8mm H, 5 Lordotic 37-6009SP 12mm W X 12mm L, 9mm H, 5 Lordotic 37-6009SP 12mm W X 12mm L, 9mm H, 5 Lordotic 37-6009SP 12mm W X 12mm L, 9mm H, 5 Lordotic 37-6010SP 12mm W X 12mm L, 10mm H, 5 Lordotic 37-6010SP 12mm W X 12mm L, 10mm H, 5 Lordotic 37-6010SP 12mm W X 12mm L, 10mm H, 5 Lordotic 37-6011SP 12mm W X 12mm L, 11mm H, 5 Lordotic 37-6011SP 12mm W X 12mm L, 11mm H, 5 Lordotic 37-6011SP 12mm W X 12mm L, 11mm H, 5 Lordotic 37-6012SP 12mm W X 12mm L, 12mm H, 5 Lordotic 37-6012SP 12mm W X 12mm L, 12mm H, 5 Lordotic 37-6012SP 12mm W X 12mm L, 12mm H, 5 Lordotic 37-6105SP 12mm W X 12mm L, 5mm H, Parallel 37-6105SP 12mm W X 12mm L, 5mm H, Parallel 37-6105SP 12mm W X 12mm L, 5mm H, Parallel 37-6106SP 12mm W X 12mm L 6mm H, Parallel 37-6106SP 12mm W X 12mm L 6mm H, Parallel 37-6106SP 12mm W X 12mm L 6mm H, Parallel 37-6107SP 12mm W X 12mm L, 7mm H, Parallel 37-6107SP 12mm W X 12mm L, 7mm H, Parallel 37-6107SP 12mm W X 12mm L, 7mm H, Parallel 37-6108SP 12mm W X 12mm L, 8mm H, Parallel 37-6108SP 12mm W X 12mm L, 8mm H, Parallel 37-6108SP 12mm W X 12mm L, 8mm H, Parallel 37-6109SP 12mm W X 12mm L, 9mm H, Parallel 37-6109SP 12mm W X 12mm L, 9mm H, Parallel 37-6109SP 12mm W X 12mm L, 9mm H, Parallel 37-6110SP 12mm W X 12mm L, 10mm H, Parallel 37-6110SP 12mm W X 12mm L, 10mm H, Parallel 37-6110SP 12mm W X 12mm L, 10mm H, Parallel 37-6111SP 12mm W X 12mm L, 11mm H, Parallel 37-6111SP 12mm W X 12mm L, 11mm H, Parallel 37-6111SP 12mm W X 12mm L, 11mm H, Parallel 37-6112SP 12mm W X 12mm L, 12mm H, Parallel 37-6112SP 12mm W X 12mm L, 12mm H, Parallel 37-6112SP 12mm W X 12mm L, 12mm H, Parallel 37-6206SP 12mm W X 12mm L, 6mm H, 10 Lordotic 37-6206SP 12mm W X 12mm L, 6mm H, 10 Lordotic 37-6206SP 12mm W X 12mm L, 6mm H, 10 Lordotic 37-6207SP 12mm W X 12mm L, 7mm H, 10 Lordotic 37-6207SP 12mm W X 12mm L, 7mm H, 10 Lordotic 37-6207SP 12mm W X 12mm L, 7mm H, 10 Lordotic 37-6208SP 12mm W X 12mm L, 8mm H, 10 Lordotic 37-6208SP 12mm W X 12mm L, 8mm H, 10 Lordotic 37-6208SP 12mm W X 12mm L, 8mm H, 10 Lordotic 37-6209SP 12mm W X 12mm L, 9mm H, 10 Lordotic 37-6209SP 12mm W X 12mm L, 9mm H, 10 Lordotic 37-6209SP 12mm W X 12mm L, 9mm H, 10 Lordotic 37-6210SP 12mm W X 12mm L, 10mm H, 10 Lordotic 37-6210SP 12mm W X 12mm L, 10mm H, 10 Lordotic 37-6210SP 12mm W X 12mm L, 10mm H, 10 Lordotic 37-6211SP 12mm W X 12mm L, 11mm H, 10 Lordotic 37-6211SP 12mm W X 12mm L, 11mm H, 10 Lordotic 37-6211SP 12mm W X 12mm L, 11mm H, 10 Lordotic | Labeling contains claims that are not consistently present. | Class III | Open, Classified | |
| Z-0895-2026 | Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 38-2006SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 6H; 38-2007SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 7H; 38-2008SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 8H; 38-2009SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 9H; 38-2010SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 10H; 38-2011SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 11H; 38-2012SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 12H; 38-2013SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 13H; 38-2014SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 14H; 38-2106SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 6H; 38-2107SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 7H; 38-2108SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 8H; 38-2109SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 9H; 38-2110SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 10H; 38-2111SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 11H; 38-2112SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 12H; 38-2113SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 13H; 38-2114SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 14H; 38-2206SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 6H; 38-2207SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 7H; 38-2208SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 8H; 38-2209SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 9H; 38-2210SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 10H; 38-2211SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 11H; 38-2212SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 12H; 38-2213SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 13H; 38-2214SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 14H; 38-2309SP FORZA Ti Spacer, Straight, 8, 11W x 27L x 9H; 38-2310SP FORZA Ti Spacer, Straight, 8, 11W x 27L x 10H; 38-2311SP FORZA Ti Spacer, Straight, 8, 11W x 27L x 11H; 38-2312SP FORZA Ti Spacer, Straight, 8, 11W x 27L x 12H; 38-2313SP FORZA Ti Spacer, Straight, 8, 11W x 27L x 13H; 38-2314SP FORZA Ti Spacer, Straight, 8, 11W x 27L x 14H; 38-2508SP FORZA Ti Spacer, Straight, 8, 9W x 23L x 8H; 38-2509SP FORZA Ti Spacer, Straight, 8, 9W x 23L x 9H; 38-2510SP FORZA Ti Spacer, Straight, 8, 9W x 23L x 10H; 38-2511SP FORZA Ti Spacer, Straight, 8, 9W x 23L x 11H; 38-2512SP FORZA Ti Spacer, Straight, 8, 9W x 23L x 12H; 38-2513SP FORZA Ti Spacer, Straight, 8, 9W x 23L x 13H; 38-2514SP FORZA Ti Spacer, Straight, 8, 9W x 23L x 14H; 38-3206SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 6H; 38-3207SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 7H; 38-3208SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 8H; 38-3209SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 9H; 38-3210SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 10H; 38-3211SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 11H; 38-3212SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 12H; 38-3213SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 13H; 38-3214SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 14H; 38-3409SP FORZA Ti Spacer, Straight, 8, 11W x 31L x 9H; 38-3410SP FORZA Ti Spacer, Straight, 8, 11W x 31L x 10H; 38-3411SP FORZA Ti Spacer, Straight, 8, 11W x 31L x 11H; 38-3412SP FORZA Ti Spacer, Straight, 8, 11W x 31L x 12H; | Labeling contains claims that are not consistently present. | Class III | Open, Classified | |
| Z-0894-2026 | Brand Name: FIREBIRD" SI Fusion System Product Name: FIREBIRD" SI Fusion System Model/Catalog Number: 18-1025SP 11mm X 25mm FIREBIRD SI Screw; 18-1030SP 11mm X 30mm FIREBIRD SI Screw; 18-1035SP 11mm X 35mm FIREBIRD SI Screw; 18-1040SP 11mm X 40mm FIREBIRD SI Screw; 18-1045SP 11mm X 45mm FIREBIRD SI Screw; 18-1050SP 11mm X 50mm FIREBIRD SI Screw; 18-1055SP 11mm X 55mm FIREBIRD SI Screw; 18-1060SP 11mm X 60mm FIREBIRD SI Screw; 18-1065SP 11mm X 65mm FIREBIRD SI Screw; 18-1070SP 11mm X 70mm FIREBIRD SI Screw; 18-2025SP 12mm X 25mm FIREBIRD SI Screw; 18-2030SP 12mm X 30mm FIREBIRD SI Screw; 18-2035SP 12mm X 35mm FIREBIRD SI Screw; 18-2040SP 12mm X 40mm FIREBIRD SI Screw; 18-2045SP 12mm X 45mm FIREBIRD SI Screw; 18-2050SP 12mm X 50mm FIREBIRD SI Screw; 18-2055SP 12mm X 55mm FIREBIRD SI Screw; 18-2060SP 12mm X 60mm FIREBIRD SI Screw; 18-2065SP 12mm X 65mm FIREBIRD SI Screw; 18-2070SP 12mm X 70mm FIREBIRD SI Screw | Labeling contains claims that are not consistently present. | Class III | Open, Classified | |
| Z-0893-2026 | Brand Name: Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer System Model/Catalog Number: 39-9012SP 33W X 28L X 12.5H, 7DEG PTC IMPLANT; 39-9014SP 33W X 28L X 14H, 7DEG PTC IMPLANT; 39-9016SP 33W X 28L X 16H, 7DEG PTC IMPLANT; 39-9018SP 33W X 28L X 18H, 7DEG PTC IMPLANT; 39-9212SP 33W X 28L X 12.5H, 12DEG PTC IMPLANT; 39-9214SP 33W X 28L X 14H, 12DEG PTC IMPLANT; 39-9216SP 33W X 28L X 16H, 12DEG PTC IMPLANT; 39-9218SP 33W X 28L X 18H, 12DEG PTC IMPLANT; 39-2012SP 37W X 28L X 12.5H, 7DEG PTC IMPLANT; 39-2014SP 37W X 28L X 14H, 7DEG PTC IMPLANT; 39-2016SP 37W X 28L X 16H, 7DEG PTC IMPLANT; 39-2018SP 37W X 28L X 18H, 7DEG PTC IMPLANT; 39-2212SP 37W X 28L X 12.5H, 12DEG PTC IMPLANT; 39-2214SP 37W X 28L X 14H, 12DEG PTC IMPLANT; 39-2216SP 37W X 28L X 16H, 12DEG PTC IMPLANT; 39-2218SP 37W X 28L X 18H, 12DEG PTC IMPLANT; | Labeling contains claims that are not consistently present. | Class III | Open, Classified | |
| Z-0892-2026 | Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System Model/Catalog Number: 38-1007SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 7H 38-1008SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 8H; 38-1009SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 9H; 38-1010SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 10H; 38-1011SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 11H; 38-1012SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 12H; 38-1013SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 13H; 38-1014SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 14H; 38-1707SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 7H; 38-1708SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 8H; 38-1709SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 9H; 38-1710SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 10H; 38-1711SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 11H; 38-1712SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 12H; 38-1713SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 13H; 38-1714SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 14H; 38-1807SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 7H; 38-1808SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 8H; 38-1809SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 9H; 38-1810SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 10H; 38-1811SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 11H; 38-1812SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 12H; 38-1813SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 13H; 38-1814SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 14H; 38-3007SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 7H; 38-3008SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 8H; 38-3009SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 9H; 38-3010SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 10H; 38-3011SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 11H; 38-3012SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 12H; 38-3013SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 13H; 38-3014SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 14H; 38-4007SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 7H; 38-4008SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 8H; 38-4009SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 9H; 38-4010SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 10H; 38-4011SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 11H; 38-4012SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 12H; 38-4013SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 13H; 38-4014SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 14H; 38-4207SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 7H; 38-4208SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 8H; 38-4209SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 9H; 38-4210SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 10H; 38-4211SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 11H; 38-4212SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 12H; 38-4213SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 13H; 38-4214SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 14H; 38-4508SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 8H; 38-4509SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 9H; 38-4510SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 10H; 38-4511SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 11H; 38-4512SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 12H; 38-4513SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 13H; 38-4514SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 14H; 38-6007SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 7H; 38-6008SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 8H; 38-6009SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 9H; 38-6010SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 10H; 38-6011SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 11H; 38-6012SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 12H; 38-6013SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 13H; 38-6014SP FORZA PTC Spacer, | Labeling contains claims that are not consistently present. | Class III | Open, Classified | |
| Z-0891-2026 | Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer System Model/Catalog Number: 37-3106SP 12mm W X 12mm L, 6mm H, Parallel; 37-3107SP 12mm W X 12mm L, 7mm H, Parallel; 37-3108SP 12mm W X 12mm L, 8mm H, Parallel; 37-3109SP 12mm W X 12mm L, 9mm H, Parallel; 37-3110SP 12mm W X 12mm L, 10mm H, Parallel; 37-3111SP 12mm W X 12mm L, 11mm H, Parallel; 37-3112SP 12mm W X 12mm L, 12mm H, Parallel; 37-3113SP 12mm W X 12mm LW, 13mm H, Parallel; 37-3114SP 12mm W X 12mm WL, 14mm H, Parallel; 37-3006SP 12mm W X 12mm L, 6mm H, 5 Lordotic; 37-3007SP 12mm W X 12mm L, 7mm H, 5 Lordotic; 37-3008SP 12mm W X 12mm L, 8mm H, 5 Lordotic; 37-3009SP 12mm WL X 12mm L, 9mm H, 5 Lordotic; 37-3010SP 12mm W X 12mm L, 10mm H, 5 Lordotic; 37-3011SP 12mm W X 12mm L, 11mm H, 5 Lordotic; 37-3012SP 12mm W X 12mm L, 12mm H, 5 Lordotic; 37-3013SP 12mm W X 12mm L, 13mm H, 5 Lordotic; 37-3014SP 12mm W X 12mm L, 14mm H, 5 Lordotic; 37-3207SP 12mm W X 12mm L, 7mm H, 10 Lordotic; 37-3208SP 12mm W X 12mm L, 8mm H, 10 Lordotic; 37-3209SP 12mm W X 12mm L, 9mm H, 10 Lordotic; 37-3210SP 12mm W X 12mm L, 10mm H, 10 Lordotic; 37-3211SP 12mm W X 12mm L, 11mm H, 10 Lordotic; 37-3212SP 12mm W X 12mm L, 12mm H, 10 Lordotic; 37-4106SP 15mm W X 12mm L, 6mm H, Parallel; 37-4107SP 15mm W X 12mm L, 7mm H, Parallel; 37-4108SP 15mm W X 12mm L, 8mm H, Parallel; 37-4109SP 15mm W X 12mm L, 9mm H, Parallel; 37-4110SP 15mm W X 12mm L, 10mm H, Parallel; 37-4111SP 15mm W X 12mm L, 11mm H, Parallel; 37-4112SP 15mm W X 12mm L, 12mm H, Parallel; 37-4113SP 15mm W X 12mm L, 13mm H, Parallel; 37-4114SP 15mm W X 12mm L, 14mm H, Parallel; 37-4006SP 15mm W X 12mm L, 6mm H, 5 Lordotic; 37-4007SP 15mm W X 12mm L, 7mm H, 5 Lordotic; 37-4008SP 15mm W X 12mm L, 8mm H, 5 Lordotic; 37-4009SP 15mm W X 12mm L, 9mm H, 5 Lordotic; 37-4010SP 15mm W X 12mm L, 10mm H, 5 Lordotic; 37-4011SP 15mm W X 12mm L, 11mm H, 5 Lordotic; 37-4012SP 15mm W X 12mm L, 12mm H, 5 Lordotic; 37-4013SP 15mm W X 12mm L, 13mm H, 5 Lordotic; 37-4014SP 15mm W X 12mm L, 14mm H, 5 Lordotic; 37-4207SP 15mm W X 12mm L, 7mm H, 10 Lordotic; 37-4208SP 15mm W X 12mm L, 8mm H, 10 Lordotic; 37-4209SP 15mm W X 12mm L, 9mm H, 10 Lordotic; 37-4210SP 15mm W X 12mm L, 10mm H, 10 Lordotic; 37-4211SP 15mm W X 12mm L, 11mm H, 10 Lordotic; 37-4212SP 15mm W X 12mm L, 12mm H, 10 Lordotic; 37-5106SP 15mm W X 15mm L, 6mm H, Parallel; 37-5107SP 15mm W X 15mm L, 7mm H, Parallel 37-5108SP 15mm W X 15mm L, 8mm H, Parallel; 37-5109SP 15mm W X 15mm L, 9mm H, Parallel; 37-5110SP 15mm W X 15mm L, 10mm H, Parallel; 37-5111SP 15mm W X 15mm L, 11mm H, Parallel; 37-5112SP 15mm W X 15mm L, 12mm H, Parallel; 37-5113SP 15mm W X 15mm L, 13mm H, Parallel; 37-5114SP 15mm W X 15mm L, 14mm H, Parallel; 37-5006SP 15mm W X 15mm L, 6mm H, 5 Lordotic; 37-5007SP 15mm W X 15mm L, 7mm H, 5 Lordotic; 37-5008SP 15mm W X 15mm L, 8mm H, 5 Lordotic; 37-5009SP 15mm W X 15mm L, 9mm H, 5 Lordotic; 37-5010SP 15mm W X 15mm L, 10mm H, 5 Lordotic; 37-5011SP 15mm W X 15mm L, 11mm H, 5 Lordotic; 37-5012SP 15mm W X 15mm L, 12mm H, 5 Lordotic; 37-5013SP 15mm W X 15mm L, 13mm H, 5 Lordotic; 37-5014SP 15mm W X 15mm L, 14mm H, 5 Lordotic; 37-5207SP 15mm W X 15mm L, 7mm H, 10 Lordotic; 37-5208SP 15mm W X 15mm L, 8mm H, 10 Lordotic; 37-5209SP 15mm W X 15mm LW, 9mm H, 10 Lordotic; 37-5210SP 15mm W X 15mm L, 10mm H, 10 Lordotic; 37-5211SP 15mm W X 15mm L, 11mm H, 10 Lordotic; 37-5212SP 15mm W X 15mm L, 12mm H, 10 Lordotic; | Labeling contains claims that are not consistently present. | Class III | Open, Classified | |
| Z-0478-2026 | Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following sizes are affected: 1. POLYAXIAL SCREW, CC, 5.5mm X 30mm; Item Number: TL1-10755030. 2. POLYAXIAL SCREW, CC, 5.5mm X 35mm; Item Number: TL1-10755035. 3. POLYAXIAL SCREW, CC, 5.5mm X 40mm; Item Number: TL1-10755040. 4. POLYAXIAL SCREW, CC, 5.5mm X 45mm; Item Number: TL1-10755045. 5. POLYAXIAL SCREW, CC, 5.5mm X 50mm; Item Number: TL1-10755050. 6. POLYAXIAL SCREW, CC, 6.5mm X 30mm; Item Number: TL1-10765030. 7. POLYAXIAL SCREW, CC, 6.5mm X 35mm; Item Number: TL1-10765035. 8. POLYAXIAL SCREW, CC, 6.5mm X 40mm; Item Number: TL1-10765040. 9. POLYAXIAL SCREW, CC, 6.5mm X 45mm; Item Number: TL1-10765045. 10. POLYAXIAL SCREW, CC, 6.5mm X 50mm; Item Number: TL1-10765050. 11. POLYAXIAL SCREW, CC, 6.5mm X 55mm; Item Number: TL1-10765055. 12. POLYAXIAL SCREW, CC, 6.5mm X 60mm; Item Number: TL1-10765060. 13. POLYAXIAL SCREW, CC, 7.5mm X 30mm; Item Number: TL1-10775030. 14. POLYAXIAL SCREW, CC, 7.5mm X 35mm; Item Number: TL1-10775035. 15. POLYAXIAL SCREW, CC, 7.5mm X 40mm; Item Number: TL1-10775040. 16. POLYAXIAL SCREW, CC, 7.5mm X 45mm; Item Number: TL1-10775045. 17. POLYAXIAL SCREW, CC, 7.5mm X 50mm; Item Number: TL1-10775050. 18. POLYAXIAL SCREW, CC, 7.5mm X 55mm; Item Number: TL1-10775055. 19. POLYAXIAL SCREW, CC, 7.5mm X 60mm; Item Number: TL1-10775060. 20. POLYAXIAL SCREW, CC, 8.5mm X 35mm; Item Number: TL1-10785035. 21. POLYAXIAL SCREW, CC, 8.5mm X 40mm; Item Number: TL1-10785040. 22. POLYAXIAL SCREW, CC, 8.5mm X 45mm; Item Number: TL1-10785045. 23. POLYAXIAL SCREW, CC, 8.5mm X 50mm; Item Number: TL1-10785050. 24. POLYAXIAL SCREW, CC, 8.5mm X 55mm; Item Number: TL1-10785055. 25. POLYAXIAL SCREW, CC, 8.5mm X 60mm; Item Number: TL1-10785060. | Polyaxial screws do not meet performance standards. | Class II | Open, Classified | |
| Z-2555-2025 | PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP | A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap information box. The 37 mm width on the front labels is correct. | Class II | Open, Classified | |
| Z-1432-2025 | Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy: (1) REF 82-3300SP, 33mm W x 24mm D x 10mm H, 7 degrees; (2) REF 82-3700SP, 37mm W x 28mm D x 10mm H, 7 degrees; and (3) REF 82-4000SP, 40mm W x 32mm D x 10mm H, 7 degrees. | The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm. | Class II | Open, Classified | |
| Z-1977-2025 | REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile | Retrospective; Their is the potential that implantable intramedullary lengthening nails may bend at the distal tail during insertion resulting in having to be replaced. | Class II | Open, Classified | |
| Z-0403-2020 | ORTHOFIX Catalogue Number: ref: 99-93601, GALAXY WRIST STERILE KIT, UDI: (01)18054242511656 | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. | Class II | Terminated | |
| Z-0402-2020 | ORTHOFIX Catalogue Number: ref: 99-93504, ELBOW STERILE KIT, UDI: (01)18054242511533 | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. | Class II | Terminated | |
| Z-0401-2020 | ORTHOFIX Catalogue Number: ref: 99-93503US, ANKLE TRANSFIX PIN STERILE KIT, UDI: (01)18054242511304 | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. | Class II | Terminated | |
| Z-0400-2020 | ORTHOFIX Catalogue Number: ref:99-93503 , ANKLE STERILE KIT, UDI: (01)18033509859922 | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. | Class II | Terminated | |
| Z-0399-2020 | ORTHOFIX Catalogue Number: ref: 99-93502US, TIBIA FEMUR DIAPHYSEAL STERILE KIT, UDI: (01)18054242S511298 | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. | Class II | Terminated | |
| Z-0398-2020 | ORTHOFIX Catalogue Number: ref: 99-93502JP, LOWER LIMB DIAPHYSEAL STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510895 | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. | Class II | Terminated | |
| Z-0397-2020 | ORTHOFIX Catalogue Number: ref: 99-93502, LOWER LIMB DIAPHYSEAL STERILE KIT, RX ONLY, UDI: (01)18033509859915 | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. | Class II | Terminated | |
| Z-0396-2020 | ORTHOFIX Catalogue Number: ref: 99-93501US, PELVIS STERILE KIT, RX ONLY, UDI: (01)180S4242S11281 | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. | Class II | Terminated | |
| Z-0395-2020 | ORTHOFIX Catalogue Number: ref: 99-93501JP, PELVIS STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510888 | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. | Class II | Terminated | |
| Z-0394-2020 | ORTHOFIX Catalogue Number: ref: 99-93501, PELVIS STERILE KIT, RX ONLY, UDI: (01)18033509859908 | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. | Class II | Terminated | |
| Z-0393-2020 | ORTHOFIX Catalogue Number: ref: 99-92504, PREFIX II ANKLE COMPLETE KIT STERILE, RX ONLY, UDI: (01)18033509855979 | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. | Class II | Terminated |
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