Exactech, Inc.
Gainesville, FL, US
EXACTECH, INC. appears in FDA device records in Gainesville, FL. FDA records list 186 510(k) clearances between and , 21 PMA records and one registered establishment. As of , FDA records show 221 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 186FDA records hold 186 510(k) clearances for Exactech, Inc. between 1986 and 2026. The busiest year on record is 2010, with 14. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 2 |
| 1989 | 2 |
| 1990 | 1 |
| 1991 | 3 |
| 1992 | 1 |
| 1993 | 3 |
| 1994 | 6 |
| 1995 | 3 |
| 1996 | 7 |
| 1999 | 2 |
| 2000 | 4 |
| 2001 | 10 |
| 2002 | 5 |
| 2003 | 5 |
| 2004 | 13 |
| 2005 | 6 |
| 2006 | 5 |
| 2007 | 5 |
| 2008 | 5 |
| 2009 | 1 |
| 2010 | 14 |
| 2011 | 10 |
| 2012 | 8 |
| 2013 | 8 |
| 2014 | 8 |
| 2015 | 9 |
| 2016 | 6 |
| 2017 | 6 |
| 2018 | 8 |
| 2019 | 4 |
| 2020 | 2 |
| 2022 | 1 |
| 2023 | 6 |
| 2024 | 2 |
| 2025 | 4 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260583 | Equinoxe® Shoulder System | PHX | Substantially Equivalent | |
| K250713 | Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants | KWT | Substantially Equivalent | |
| K243448 | Equinoxe® Shoulder System | PHX | Substantially Equivalent | |
| K243275 | Equinoxe® Scapula Fracture System | HRS | Substantially Equivalent | |
| K243839 | Alteon® HA Femoral Stems | MEH | Substantially Equivalent | |
| K240393 | Exactech® TRULIANT® Knee System | MBH | Substantially Equivalent | |
| K233482 | Equinoxe® Central Screw Baseplate System | PHX | Substantially Equivalent | |
| K230717 | Exactech® Vantage® Total Ankle System | HSN | Substantially Equivalent | |
| K223933 | Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws | HRS | Substantially Equivalent | |
| K223833 | Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays | PHX | Substantially Equivalent | |
| K232002 | Vantage® Total Ankle System | HSN | Substantially Equivalent | |
| K223252 | TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas | JWH | Substantially Equivalent | |
| K221323 | Exactech® Alteon® Short Tapered Wedge | LZO | Substantially Equivalent | |
| K212356 | Exactech® Equinoxe® Laser Cage Glenoid | KWS | Substantially Equivalent | |
| K192097 | Exactech® Equinoxe® Stemless Humeral Components | PKC | Substantially Equivalent | |
| K193098 | Exactech® Equinoxe® Reverse Shoulder Glenospheres | PHX | Substantially Equivalent | |
| K190890 | Exactech Alteon Modular Dual Mobility (MDM) System | LZO | Substantially Equivalent | |
| K191561 | Exactech Equinoxe Humeral Augmented Trays | PHX | Substantially Equivalent | |
| K183343 | Vantage Total Ankle Flat Cut Talar Components | HSN | Substantially Equivalent | |
| K182502 | Alteon Acetabular Cup System | LPH | Substantially Equivalent | |
| K182346 | TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws | MBH | Substantially Equivalent | |
| K182462 | Exactech Alteon Highly Polished Femoral Stem | LZO | Substantially Equivalent | |
| K182536 | Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse Shoulder Humeral Liners , Exactech Equinoxe Small Reverse Shoulder Glenoid Plates , Exactech Equinoxe Reverse Shoulder Locking Cap | PHX | Substantially Equivalent | |
| K181794 | Truliant Porous Femoral Components | MBH | Substantially Equivalent | |
| K181532 | Exactech Alteon Monobloc Revision Stem | LZO | Substantially Equivalent | |
| K180632 | Exactech Equinoxe Small Reverse Shoulder System | PHX | Substantially Equivalent | |
| K173583 | Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners | OQI | Substantially Equivalent | |
| K173388 | Exactech Equinoxe Stemless Shoulder | PKC | Substantially Equivalent | |
| K171045 | Exactech® Truliant™ Line Extensions | JWH | Substantially Equivalent | |
| K162732 | Exactech® Alteon® HA Femoral Stem | MEH | Substantially Equivalent | |
| K162325 | Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw | PHX | Substantially Equivalent | |
| K162903 | Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies | KWT | Substantially Equivalent | |
| K170240 | Truliant Femoral Components | JWH | Substantially Equivalent | |
| K162726 | Exactech® Equinoxe® Preserve Stem | PHX | Substantially Equivalent | |
| K153649 | Exactech® Novation® Element Press-fit Femoral Stem | MEH | Substantially Equivalent | |
| K160697 | Gibralt® Spine System and Gibralt® Occipital Spine System | NKG | Substantially Equivalent | |
| K153595 | Optetrak Logic Metaphyseal Cones | JWH | Substantially Equivalent | |
| K160484 | Optetrak Advanced Patella | JWH | Substantially Equivalent | |
| K153776 | Optetrak One Logic Femoral Components | MBH | Substantially Equivalent | |
| K152217 | Exactech Vantage Total Ankle System | HSN | Substantially Equivalent | |
| K152170 | Exactech Optetrak Logic Enhanced Assembly | JWH | Substantially Equivalent | |
| K141960 | Exactech® Novation® Crown Cup® | LPH | Substantially Equivalent | |
| K150066 | Exactech Alteon Monobloc Revision Stem | LZO | Substantially Equivalent | |
| K150890 | Exactech Optetrak Logic CC | JWH | Substantially Equivalent | |
| K150130 | Ascendant TM Cervical Spacer System | ODP | Substantially Equivalent | |
| K150458 | Exactech Equinoxe Reverse Shoulder 46x21mm Glenosphere | PHX | Substantially Equivalent | |
| K150152 | The Octane Straight Intervertebral Fusion Device, Ti Coated | MAX | Substantially Equivalent | |
| K143659 | Equinoxe Mega Prosthesis | KWT | Substantially Equivalent | |
| K143576 | Exactech Ambassador | KWQ | Substantially Equivalent | |
| K141821 | ALTEON NECK PRESERVING FEMORAL STEM, STANDARD OFFSET, SIZE 6-7; ALTEON NECK PRESERVING FEMORAL STEM, EXTENDED OFFSET | LZO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1038671 | 1038671 | EXACTECH, INC. | 2320 N.W. 66TH CT., GAINESVILLE, FL 32653 US | 2026 | and 53 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- HTWBit, Drill
- GFABlade, Saw, General & Plastic Surgery, Surgical
- LODBone Cement
- HXYBrace, Drill
- HTQBroach
- KDGChisel (Osteotome)
- FZSCurette, Surgical, General Use
- HWRDriver, Prosthesis
- HTEElevator
- HWBExtractor
- HTPFile
- MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)
- HTJGauge, Depth
- GDHGouge, Surgical, General & Plastic Surgery
- FZXGuide, Surgical, Instrument
- KIKHook, Bone
- HWAImpactor
- HWNInstrument, Compression
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- HSZInstrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- KDDKit, Surgical Instrument, Disposable
- JDZMixer, Cement, For Clinical Use
- LXHOrthopedic Manual Surgical Instrument
- HWMOsteotome
- HRSPlate, Fixation, Bone
- KILPositioner, Socket
- HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
- JDKProsthesis, Hip, Cement Restrictor
- KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
- JDGProsthesis, Hip, Femoral Component, Cemented, Metal
- KWLProsthesis, Hip, Hemi-, Femoral, Metal
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- JDLProsthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
- HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
- MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- HWPPunch, Femoral Neck
- HTRRasp
- HTOReamer
- GADRetractor
- HWCScrew, Fixation, Bone
- HXXScrewdriver
- JDRStaple, Fixation, Bone
- HWDStarter, Bone Screw
- HRTStripper, Surgical
- HXGTamp
- HWTTemplate
- FSMTray, Surgical, Instrument
- HXCWrench
Recall records
Showing 25 of 221| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1510-2026 | Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X | Impactor handle may be missing cross-pin | Class II | Open, Classified | |
| Z-1509-2026 | Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05 | Impactor handle may be missing cross-pin | Class II | Open, Classified | |
| Z-0537-2026 | Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Description: Pilot Tip Converter Piece Component: Not a component | Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria. | Class II | Open, Classified | |
| Z-0536-2026 | Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product Description: rTSA Reamer, 46mm Component: Not a component | Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria. | Class II | Open, Classified | |
| Z-0535-2026 | Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product Description: rTSA Reamer, 42mm Component: Not a component | Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria. | Class II | Open, Classified | |
| Z-2562-2025 | Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINER +2.5), REF:322-42-00 (145-DEG PE 42MM HUM LINER +0), REF: 322-42-03 (145-DEG PE 42MM HUM LINER +2.5) | Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling. | Class II | Open, Classified | |
| Z-2561-2025 | Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0/ 320-42-03,145-DEG PE 42MM HUM LINER +2.5/ | Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling. | Class II | Open, Classified | |
| Z-1167-2025 | Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1 28MM 140-28-52 NV EHXL NTRL LNR G228MM 140-32-51 NV EHXL NTRL LNR G132MM 140-32-52 NV EHXL NTRL LNR G232MM 140-32-53 NV EHXL NTRL LNR G332MM 140-32-54 NV EHXLNTRL LNR G4 32MM 140-32-55 NV EHXLNTRL LNR G5 32MM 140-36-52 NV EHXLNTRL LNR G2 36MM 140-36-53 NV EHXL NTRL LNR G336MM 140-36-54 NV EHXLNTRL LNR G4 36MM 140-36-55 NV EHXLNTRL LNR G5 36MM 140-40-53 NV EHXLNTRL LNR G3 40MM 140-40-54 NV EHXLNTRL LNR G4 40MM 140-40-55 NV EHXLNTRL LNR G5 40MM 142-22-68 NV EHXL ALPLNR G00 22MM 142-22-70 NV EHXL LIPLNR G00 22MM 142-28-50 NV EHXL LIP LNR G0 28MM 142-28-51 NV EHXL LIP LNR G1 28MM 142-28-52 NV EHXL LIP LNR G2 28MM 142-28-60 NV EHXL ALIPLNR G0 28MM 142-28-61 NV EHXL ALIP LNR G1 28MM 142-28-62 NV EHXL ALIP LNR G2 28MM 142-32-51 NV EHXL LIP LNR G1 32MM 142-32-52 NV EHXL LIP LNR G2 32MM 142-32-53 NV EHXL LIP LNR G3 32MM 142-32-54 NV EHXL LIP LNR G4 32MM 142-32-55 NV EHXL LIP LNR G5 32MM 142-32-61 NV EHXL ALIP LNR G1 32MM 142-32-62 NV EHXL ALIP LNR G2 32MM 142-32-63 NV EHXL ALIP LNR G3 32MM 142-32-64 NV EHXL ALIP LNR G4 32MM 142-32-65 NV EHXL ALIP LNR G5 32MM 142-36-52 NV EHXL LIP LNR G2 36MM 142-36-53 NV EHXL LIP LNR G3 36MM 142-36-54 NV EHXL LIP LNR G4 36MM 142-36-55 NV EHXL LIP LNR G5 36MM 142-36-62 NV EHXL ALIP LNR G2 36MM 142-36-63 NV EHXL ALIP LNR G3 36MM 142-36-64 NV EHXL ALIP LNR G4 36MM 142-36-65 NV EHXL ALIP LNR G5 36MM 142-40-53 NV EHXL LIP LNR G3 40MM 142-40-54 NV EHXL LIP LNR G4 40MM 142-40-55 NV EHXL LIP LNR G5 40MM 142-40-63 NV EHXL ALIP LNR G3 40MM 142-40-64 NV EHXL ALIP LNR G4 40MM 142-40-65 NV EHXL ALIP LNR G5 40MM 146-22-70 NV EHXL LATLNR G00 22MM 146-28-51 NV EHXL LAT LNR G1 28MM 146-32-51 NV EHXL LAT LNR G1 32MM 146-32-52 NV EHXL LAT LNR G2 32MM 146-32-53 NV EHXL LAT LNR G3 32MM 146-32-54 NV EHXL LAT LNR G4 32MM 146-32-55 NV EHXL LAT LNR G5 32MM 146-36-52 NV EHXL LAT LNR G2 36MM 146-36-53 NV EHXL LAT LNR G3 36MM 146-36-54 NV EHXL LAT LNR G4 36MM 146-36-55 NV EHXL LAT LNR G5 36MM 146-40-53 NV EHXL LAT LNR G3 40MM 146-40-54 NV EHXL LAT LNR G4 40MM 146-40-55 NV EHXL LAT LNR G5 40MM 148-32-51 NV EHXL 10 LNR G1 32MM 148-36-52 NV EHXL 10 LNR G2 36MM 148-36-53 NV EHXL 10 LNR G3 36MM 148-36-54 NV EHXL 10 LNR G4 36MM 148-36-55 NV EHXL 10 LNR G5 36MM 148-40-53 NV EHXL 10 LNR G3 40MM 148-40-54 NV EHXL 10 LNR G4 40MM 148-40-55 NV EHXL 10 LNR G5 40MM All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. | Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. | Class II | Open, Classified | |
| Z-1166-2025 | Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1 28MM 140-28-52 NV EHXL NTRL LNR G228MM 140-32-51 NV EHXL NTRL LNR G132MM 140-32-52 NV EHXL NTRL LNR G232MM 140-32-53 NV EHXL NTRL LNR G332MM 140-32-54 NV EHXLNTRL LNR G4 32MM 140-32-55 NV EHXLNTRL LNR G5 32MM 140-36-52 NV EHXLNTRL LNR G2 36MM 140-36-53 NV EHXL NTRL LNR G336MM 140-36-54 NV EHXLNTRL LNR G4 36MM 140-36-55 NV EHXLNTRL LNR G5 36MM 140-40-53 NV EHXLNTRL LNR G3 40MM 140-40-54 NV EHXLNTRL LNR G4 40MM 140-40-55 NV EHXLNTRL LNR G5 40MM 142-22-68 NV EHXL ALPLNR G00 22MM 142-22-70 NV EHXL LIPLNR G00 22MM 142-28-50 NV EHXL LIP LNR G0 28MM 142-28-51 NV EHXL LIP LNR G1 28MM 142-28-52 NV EHXL LIP LNR G2 28MM 142-28-60 NV EHXL ALIPLNR G0 28MM 142-28-61 NV EHXL ALIP LNR G1 28MM 142-28-62 NV EHXL ALIP LNR G2 28MM 142-32-51 NV EHXL LIP LNR G1 32MM 142-32-52 NV EHXL LIP LNR G2 32MM 142-32-53 NV EHXL LIP LNR G3 32MM 142-32-54 NV EHXL LIP LNR G4 32MM 142-32-55 NV EHXL LIP LNR G5 32MM 142-32-61 NV EHXL ALIP LNR G1 32MM 142-32-62 NV EHXL ALIP LNR G2 32MM 142-32-63 NV EHXL ALIP LNR G3 32MM 142-32-64 NV EHXL ALIP LNR G4 32MM 142-32-65 NV EHXL ALIP LNR G5 32MM 142-36-52 NV EHXL LIP LNR G2 36MM 142-36-53 NV EHXL LIP LNR G3 36MM 142-36-54 NV EHXL LIP LNR G4 36MM 142-36-55 NV EHXL LIP LNR G5 36MM 142-36-62 NV EHXL ALIP LNR G2 36MM 142-36-63 NV EHXL ALIP LNR G3 36MM 142-36-64 NV EHXL ALIP LNR G4 36MM 142-36-65 NV EHXL ALIP LNR G5 36MM 142-40-53 NV EHXL LIP LNR G3 40MM 142-40-54 NV EHXL LIP LNR G4 40MM 142-40-55 NV EHXL LIP LNR G5 40MM 142-40-63 NV EHXL ALIP LNR G3 40MM 142-40-64 NV EHXL ALIP LNR G4 40MM 142-40-65 NV EHXL ALIP LNR G5 40MM 146-22-70 NV EHXL LATLNR G00 22MM 146-28-51 NV EHXL LAT LNR G1 28MM 146-32-51 NV EHXL LAT LNR G1 32MM 146-32-52 NV EHXL LAT LNR G2 32MM 146-32-53 NV EHXL LAT LNR G3 32MM 146-32-54 NV EHXL LAT LNR G4 32MM 146-32-55 NV EHXL LAT LNR G5 32MM 146-36-52 NV EHXL LAT LNR G2 36MM 146-36-53 NV EHXL LAT LNR G3 36MM 146-36-54 NV EHXL LAT LNR G4 36MM 146-36-55 NV EHXL LAT LNR G5 36MM 146-40-53 NV EHXL LAT LNR G3 40MM 146-40-54 NV EHXL LAT LNR G4 40MM 146-40-55 NV EHXL LAT LNR G5 40MM 148-32-51 NV EHXL 10 LNR G1 32MM 148-36-52 NV EHXL 10 LNR G2 36MM 148-36-53 NV EHXL 10 LNR G3 36MM 148-36-54 NV EHXL 10 LNR G4 36MM 148-36-55 NV EHXL 10 LNR G5 36MM 148-40-53 NV EHXL 10 LNR G3 40MM 148-40-54 NV EHXL 10 LNR G4 40MM 148-40-55 NV EHXL 10 LNR G5 40MM All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. | Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. | Class II | Open, Classified | |
| Z-1165-2025 | AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0 LNR G 28MM 140-32-27 AM EHXL 0 LNR G 32MM 140-32-28 AM EHXL 0 LNR H 32MM 140-28-29 AM EHXL 0 LNR J 28MM 140-32-29 AM EHXL 0 LNR J 32MM 140-36-29 AM EHXL 0 LNR J 36MM 140-32-30 AM EHXL 0 LNR K 32MM 140-36-30 AM EHXL 0 LNR K 36MM 140-28-25 AM EHXL 0LNR E 28MM 140-28-26 AM EHXL 0LNR F 28MM 140-28-28 AM EHXL 0LNR H 28MM 140-36-28 AM EHXL 0LNR H 36MM 140-28-30 AM EHXL 0LNR K 28MM 142-28-24 AM EHXL 15 LNR D 28MM 142-28-26 AM EHXL 15 LNR F 28MM 142-32-27 AM EHXL 15 LNR G 32MM 142-32-28 AM EHXL 15 LNR H 32MM 142-36-28 AM EHXL 15 LNR H 36MM 142-36-29 AM EHXL 15 LNR J 26MM 142-28-29 AM EHXL 15 LNR J 28MM 142-32-29 AM EHXL 15 LNR J 32MM 142-28-30 AM EHXL 15 LNR K 28MM 142-32-30 AM EHXL 15 LNR K 32MM 142-36-30 AM EHXL 15 LNR K 36MM 142-28-25 AM EHXL 15LNR E 28MM 142-28-27 AM EHXL 15LNR G 28MM 142-28-28 AM EHXL 15LNR H 28MM 144-28-28 AM EHXL EXT LNR H 28MM 144-28-29 AM EHXL EXT LNR J 28MM 144-28-25 AM EHXL EXTLNR E 28MM 144-28-26 AM EHXL EXTLNR F 28MM 144-28-27 AM EHXL EXTLNR G 28MM 144-28-30 AM EHXL EXTLNR K 28MM 148-28-26 AM EHXL LAT LNR F 28MM 148-28-27 AM EHXL LAT LNR G 28MM 148-36-28 AM EHXL LAT LNR H 36MM 148-36-29 AM EHXL LAT LNR J 36MM 148-28-30 AM EHXL LAT LNR K 28MM 148-36-30 AM EHXL LAT LNR K 36MM 148-28-25 AM EHXL LATLNR E 28MM 148-28-28 AM EHXL LATLNR H 28MM 148-28-29 AM EHXL LATLNR J 28MM All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. | Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. | Class II | Open, Classified | |
| Z-2236-2024 | Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R; f) 100-22-24, SZ. S; g) 100-22-25, SZ. T | The AcuMatch L-Series 22mm Inner Diameter Bipolar Hip Liner lots were packaged without the specified ethylene vinyl alcohol (EVOH) layer. Between 2004 and August 2021, our packaging process utilized two different types of packaging materials: 1) Low Density Polyethylene (LDPE), Nylon, and EVOH, or 2) LDPE and Nylon without EVOH. | Class II | Open, Classified | |
| Z-2158-2024 | OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM; b) 200-07-29, 29MM; c) 200-07-32, 32MM; d) 200-07-35, 35MM; e) 200-07-38, 38MM | Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags. | Class II | Open, Classified | |
| Z-2157-2024 | OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM | Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags. | Class II | Open, Classified | |
| Z-2156-2024 | OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03-32, 32MM; d) 200-03-35, 35MM; e) 200-03-38, 38MM; f) 200-03-41, 41MM | Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags. | Class II | Open, Classified | |
| Z-2155-2024 | OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM; | Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags. | Class II | Open, Classified | |
| Z-1425-2024 | Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoulder Arthroplasty | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). | Class II | Open, Classified | |
| Z-1424-2024 | Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). | Class II | Open, Classified | |
| Z-1423-2024 | Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). | Class II | Open, Classified | |
| Z-1422-2024 | Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). | Class II | Open, Classified | |
| Z-1421-2024 | Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, Shoulder Arthroplasty | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). | Class II | Open, Classified | |
| Z-1420-2024 | Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). | Class II | Open, Classified | |
| Z-1419-2024 | Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). | Class II | Open, Classified | |
| Z-1418-2024 | Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). | Class II | Open, Classified | |
| Z-1417-2024 | Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). | Class II | Open, Classified | |
| Z-1416-2024 | Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). | Class II | Open, Classified |
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