TORNIER Inc.
Bloomington, MN, US
TORNIER Inc. appears in FDA device records in Bloomington, MN. FDA records list 140 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 61 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to TORNIER Inc. 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.
- Axya Medical, Inc.510(k), recall
- Orthohelix Surgical Designs, Inc.510(k), enforcement report, recall
510(k) clearance history
Showing 50 of 140FDA records hold 140 510(k) clearances for TORNIER Inc. between 1995 and 2026. The busiest year on record is 2006, with 15. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 1 |
| 1997 | 1 |
| 1998 | 3 |
| 1999 | 2 |
| 2000 | 9 |
| 2001 | 5 |
| 2002 | 3 |
| 2003 | 4 |
| 2004 | 5 |
| 2005 | 6 |
| 2006 | 15 |
| 2007 | 4 |
| 2008 | 6 |
| 2009 | 7 |
| 2010 | 8 |
| 2011 | 10 |
| 2012 | 15 |
| 2013 | 7 |
| 2014 | 6 |
| 2015 | 4 |
| 2016 | 2 |
| 2017 | 1 |
| 2018 | 3 |
| 2019 | 3 |
| 2020 | 2 |
| 2021 | 2 |
| 2022 | 2 |
| 2023 | 1 |
| 2025 | 1 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260721 | Tornier Perform Advanced Glenoid | KWS | Substantially Equivalent | |
| K252788 | Tornier Perform™ Reversed Monopost Glenoid (Perform Mono) | PHX | Substantially Equivalent | |
| K251686 | Tornier Humeral Reconstruction System Max (Tornier HRS Max) | KWT | Substantially Equivalent | |
| K230352 | Tornier Humeral Nail and Tornier Long Humeral Nail | HSB | Substantially Equivalent | |
| K220914 | Tornier Perform Humeral System – Fracture | PHX | Substantially Equivalent | |
| K220418 | Tornier Perform Humeral System – Stemless | PKC | Substantially Equivalent | |
| K211359 | Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation | PHX | Substantially Equivalent | |
| K213124 | Tomier Perform™ Reversed Glenoid Cannulated Glenospheres | PHX | Substantially Equivalent | |
| K201315 | PERFORM Humeral System – Stem | PAO | Substantially Equivalent | |
| K193247 | LATITUDE EV™ Total Elbow Arthroplasty | JDB | Substantially Equivalent | |
| K191711 | ORTHOLOC™ SPS Shoulder Plating System | HRS | Substantially Equivalent | |
| K191318 | AEQUALIS FLEX REVIVE Shoulder System | KWS | Substantially Equivalent | |
| K183696 | Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid | PHX | Substantially Equivalent | |
| K182461 | LATITUDE EV Total Elbow Arthroplasty | JDB | Substantially Equivalent | |
| K181587 | ORTHOLOC SPS Shoulder Plating System | HRS | Substantially Equivalent | |
| K181420 | Aequalis Flex Revive Shoulder System | KWS | Substantially Equivalent | |
| K171010 | Latitude EV Total Elbow Arthroplasty | JDB | Substantially Equivalent | |
| K161742 | Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid | PHX | Substantially Equivalent | |
| K160975 | Aequalis PerFORM+ Shoulder System | KWS | Substantially Equivalent | |
| K150871 | ForeFoot STP System | HWC | Substantially Equivalent | |
| K150715 | 2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors | MBI | Substantially Equivalent | |
| K150583 | Aequalis PerFORM+ Shoulder System | KWS | Substantially Equivalent | |
| K143552 | Simpliciti Shoulder System | PKC | Substantially Equivalent | |
| K142148 | ORTHOHELIX STAPLE SYSTEM | JDR | Substantially Equivalent | |
| K141004 | INTRAOSSEOUS FIXATION SYSTEM | HTY | Substantially Equivalent | |
| K141301 | MAXLOCK EXTREME ELBOW FRACTURE SYSTEM | HRS | Substantially Equivalent | |
| K141029 | TORNIER AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEM | PHX | Substantially Equivalent | |
| K133777 | TORNIER INSITE(TM) FT PEEK KNOTLESS SUTURE ANCHOR | MBI | Substantially Equivalent | |
| K132733 | ORTHOHELIX SYNDESMOSIS FIXATION DEVICES | HTN | Substantially Equivalent | |
| K133376 | AEQUALIS HUMERAL NAIL; SIZES 7MM & 8MM X 210, 230, 250, 270MM; LEFT AND RIGHT | HSB | Substantially Equivalent | |
| K132632 | TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLES | MBI | Substantially Equivalent | |
| K132591 | MAXLOCK EXTREME SYSTEM | HRS | Substantially Equivalent | |
| K130832 | ORTHOHELIX STAPLE SYSTEM | JDR | Substantially Equivalent | |
| K131324 | MAXTORQUE SCREW SYSTEM | HWC | Substantially Equivalent | |
| K122635 | TORNIER INSITE FT BIOCOMPOSITE SUTURE ANCHOR | MAI | Substantially Equivalent | |
| K130422 | PHANTOM FIBER BIOFIBER SUTURE | NWJ | Substantially Equivalent | |
| K123203 | MAXLOCK EXTREME SYSTEM MODEL MXL | HRS | Substantially Equivalent | |
| K122487 | BIOFIBER SYTURE | NWJ | Substantially Equivalent | |
| K122005 | MAXLOCK EXTREME SYSTEM | HRS | Substantially Equivalent | |
| K120262 | HLS UNI EVOLUTION & U-KNEETEC | HSX | Substantially Equivalent | |
| K120739 | AEQUALIS ADJUSTABLE MODULAR REVERSE SHOULDER SYSTEM | PHX | Substantially Equivalent | |
| K121493 | ASCEND SHOULDER SYSTEM | KWS | Substantially Equivalent | |
| K121437 | MINI MAXLOCK EXTREME PLATING SYSTEM | HRS | Substantially Equivalent | |
| K120165 | INTRAOSSEOUS FIXATION SYSTEM | HTY | Substantially Equivalent | |
| K120794 | ASCEND SHOULDER SYSTEM | KWS | Substantially Equivalent | |
| K120157 | MINI MAXLOCK EXTREME PLATING SYSTEM | HRS | Substantially Equivalent | |
| K112144 | AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESIS | PHX | Substantially Equivalent | |
| K113413 | ASCEND SHOULDER SYSTEM | KWS | Substantially Equivalent | |
| K111970 | KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT | KRR | Substantially Equivalent | |
| K113048 | MAXLOCK EXTREME SYSTEM | HRS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004983210 | 3004983210 | TORNIER Inc. | 4375 E. Park 30 Drive, Columbia City, IN 46725 US | 2026 | and 50 more, listed in full below |
| 1649390 | 3000718467 | TORNIER, INC. | 10801 Nesbitt Avenue South, Bloomington, MN 55437 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
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- KTWAppliance, Fixation, Nail/Blade/Plate Combination, Single Component
- HWJAwl
- HXWBender
- HTWBit, Drill
- GFGBit, Surgical
- GFABlade, Saw, General & Plastic Surgery, Surgical
- HTQBroach
- HXDClamp
- HWWCountersink
- HTFCurette
- HWRDriver, Prosthesis
- HWBExtractor
- HTDForceps
- HTJGauge, Depth
- GDFGuide, Needle, Surgical
- FZXGuide, Surgical, Instrument
- KIKHook, Bone
- HWAImpactor
- HXPInstrument, Bending Or Contouring
- HWNInstrument, Compression
- HTZInstrument, Cutting, Orthopedic
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- HXLMallet
- FTMMesh, Surgical
- FTLMesh, Surgical, Polymeric
- GABNeedle, Suturing, Disposable
- HWMOsteotome
- HWQPasser
- HXIPasser, Wire, Orthopedic
- HTYPin, Fixation, Smooth
- JDWPin, Fixation, Threaded
- HRSPlate, Fixation, Bone
- HXBProbe
- HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
- JDCProsthesis, Elbow, Constrained, Cemented
- KWIProsthesis, Elbow, Hemi-, Radial, Polymer
- JDBProsthesis, Elbow, Semi-Constrained, Cemented
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- HXOPusher, Socket
- HTRRasp
- GADRetractor
- HSBRod, Fixation, Intramedullary And Accessories
- HWCScrew, Fixation, Bone
- HXXScrewdriver
- JDRStaple, Fixation, Bone
- GATSuture, Nonabsorbable, Synthetic, Polyethylene
- GAWSuture, Nonabsorbable, Synthetic, Polypropylene
- HXGTamp
- HWXTap, Bone
- HWTTemplate
- FSMTray, Surgical, Instrument
- HWKTrephine
- HTNWasher, Bolt Nut
- HXCWrench
Recall records
Showing 25 of 61| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1769-2026 | Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 2. TORNIER HRS Max Tuberosity Body No Coat, Small, Cat. No. ARS1041102 3. TORNIER HRS Max Trial, Cat. No. ARS10252 | Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system. | Class II | Open, Classified | |
| Z-1237-2026 | TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318 | A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery, the issue may cause a minor delay in surgery. If not detected and incorrect screw is used, issue may increase risk of earlier mechanical failure, loosening, and need for revision surgery. | Class II | Open, Classified | |
| Z-1651-2025 | stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Semi-Constrained, Cemented | A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking. " Laser Marked: 9030103, Humeral Stem Trial 150mm Large / Right, Yellow color indicator (incorrect) " Device Actually: 9030092, Humeral Stem Trial 150mm Medium / Left, Red color indicator (correct) | Class II | Open, Classified | |
| Z-3155-2024 | stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder | One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device). | Class II | Open, Classified | |
| Z-3309-2024 | Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty | Devices from one lot of Perform" Reversed Inserts may contain a locking ring that was assembled upside down which would prevent the humeral insert from securely seating in the stem or spacer. | Class II | Open, Classified | |
| Z-0773-2024 | Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile. | The incorrect device is contained in the labeled package. | Class II | Open, Classified | |
| Z-0113-2024 | stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502 | One lot of Tournier Perform Reversed Lateralized Baseplates were found to have been manufactured with 6mm spacers instead of 3mm spacers. This nonconformance prevents the central screw from being able to thread into the baseplate. | Class II | Open, Classified | |
| Z-2020-2023 | AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118 | A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it was a Aequalis Flex Revive Assembly Screw 0mm Short (ARS655118) & vice versa. | Class II | Open, Classified | |
| Z-2019-2023 | AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101 | A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it was a Aequalis Flex Revive Assembly Screw 0mm Short (ARS655118) & vice versa. | Class II | Open, Classified | |
| Z-1216-2022 | Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit | The device is unable to meet sterilization requirements when sterilized per instructions in an Aesculap container. | Class II | Open, Classified | |
| Z-2025-2021 | Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component. | Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness. | Class II | Terminated | |
| Z-0405-2020 | Aequalis Ascend Flex Humeral Stem: Part Number UDI DWF601A 3700386944475 DWF601B 3700386944482 DWF601C 3700386944499 DWF602A 3700386944505 DWF602B 3700386944512 DWF602C 3700386944529 DWF603A 3700386944536 DWF603B 3700386944543 DWF603C 3700386944550 DWF604A 3700386944567 DWF604B 3700386944574 DWF605A 3700386944598 DWF605B 3700386944604 DWF605C 3700386944611 DWF606A 3700386944628 DWF606B 3700386944635 DWF606C 3700386944642 DWF607A 3700386944659 DWF607B 3700386944666 DWF607C 3700386944673 DWF608A 3700386944680 DWF608B 3700386944697 DWF608C 3700386944703 DWF609A 3700386944710 DWF609B 3700386944727 DWF609C 3700386944734 DWF611A 3700386944741 DWF611B 3700386944758 DWF611C 3700386944765 DWF612A 3700386944772 DWF612B 3700386944789 DWF612C 3700386944796 DWF613A 3700386944802 DWF613B 3700386944819 DWF613C 3700386944826 DWF614A 3700386944833 DWF614B 3700386944840 DWF614C 3700386944857 DWF615A 3700386944864 DWF615B 3700386944871 DWF615C 3700386944888 DWF616A 3700386944895 DWF616B 3700386944901 DWF616C 3700386944918 DWF617A 3700386944925 DWF617B 3700386944932 DWF617C 3700386944949 DWF618A 3700386944956 DWF618B 3700386944963 DWF618C 3700386944970 DWF619A 3700386944987 DWF619B 3700386944994 DWF619C 3700386945007 DWF702A 3700386945045 DWF702B 3700386945052 DWF702C 3700386945069 DWF703A 3700386945076 DWF703B 3700386945083 DWF703C 3700386945090 DWF704A 3700386945106 DWF704B 3700386945113 DWF704C 3700386945120 DWF705A 3700386945137 DWF705B 3700386945144 DWF705C 3700386945151 DWF706A 3700386945168 DWF706B 3700386945175 DWF706C 3700386945182 DWF707A 3700386945199 DWF707B 3700386945205 DWF707C 3700386945212 DWF708A 3700386945229 DWF708B 3700386945236 DWF708C 3700386945243 DWF709A 3700386945250 DWF709B 3700386945267 DWF709C 3700386945274 DWF712A 3700386945311 DWF712B 3700386945328 DWF712C 3700386945335 DWF713A 3700386945342 DWF713B 3700386945359 DWF713C 3700386945366 DWF714A 3700386945373 DWF714B 3700386945380 DWF714C 3700386945397 DWF715A 3700386945403 DWF715B 3700386945410 DWF715C 3700386945427 DWF716A 3700386945434 DWF716B 3700386945441 DWF716C 3700386945458 DWF717A 3700386945465 DWF717B 3700386945472 DWF717C 3700386945489 DWF718A 3700386945496 DWF718B 3700386945502 DWF718C 3700386945519 DWF719A 3700386945526 DWF719B 3700386945533 DWF719C 3700386945540 Product Usage: The AEQUALIS ASCEND FLEX Convertible Shoulder System is intended for use as: A replacement of shoulder joints in primary anatomic or primary reverse. A replacement of other shoulder joint devices in case of revisions, if sufficient bone stock remains. The AEQUALIS ASCEND FLEX Convertible Shoulder System also allows for conversions from anatomic to reverse shoulder prosthesis in case of revision. | During shipping, it is possible for the Aequalis Ascend Flex humeral stem to become unseated or otherwise move within its internal packaging restraints. Movement within the packaging may cause the product to rub against the PETG blister shipping container causing the transfer of PETG material from the blister container to the stem. | Class II | Terminated | |
| Z-1757-2018 | AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis Humeral Nail system is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications according to AO classification include Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact humeral head, or Humeral Fractures according to Neer-Classification (2, 3 and 4 part fractures). | Drill bit tips without new BargerGard tip protector may puncture through sterile packaging. | Class II | Terminated | |
| Z-1374-2018 | Fornier Phantom Fiber(TM) Sutures: Item Number Description SMB000425 4.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMB000525 5.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMP000425 4.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMP000525 5.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMSB0110 1PK PHANTOM FIBER SZ 2 WHITE SMSB0110N lPK BIOFIBER SUTURE SZ 2 WHT NEEDLED SMSB0112 10 PK PHANTOM FIBER SZ 2 WHITE SMSB0112N 10 PK PHANTOM FIBER SUTURE SZ 2WHT NEEDLED SMSB0120 1PK PHANTOM FIBER SZ 2 VIOLET SMSB0120N lPK BIOFIBER SUTURE SZ 2 VLT NEEDLED SMSB0122 10 PK PHANTOM FIBER SZ 2 VIOLET SMSB0122N 10 PK BIOFIBER SUTURE SZ 2 VLT NEEDLED SMSB0130 1PK PHANTOM FIBER SZ 2 WHITE/VIOLET SMSB0132 10 PK PHANTOM FIBER SZ 2 WHITE/VIOLET Indications for use for the Phantom Fiber are: Phantom Fiber suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery. | Data has shown that degradation of a raw material used in Phantom Fiber may occur more quickly than expected if improperly stored. This may impact the shelf-life of the product which could cause the suture to lose strength more quickly than expected. | Class II | Terminated | |
| Z-0699-2017 | Aequalis Fx2 implant parts and instrument trays. Insert component : Part Numbers DWK204B-DWK206B, DWK224B-DWK226B, DWK230B-DWK23B, DWK244B-DWK246B, DWK250B-DWK252B, DWK264B-DWK266B, DWK270B-DWK272B. Stem Component: Part Number: DWK111B-DWK115B, DWK121B-DWK126B, DWK131B-DWK135B. Product Usage: Total or partial replacement of the Gleno-humeral articulation. | Tornier is conducting a recall on Aequalis Fx2 ( implant parts and instrument trays) due to reports of dislocations of the poly insert and the stem. | Class II | Terminated | |
| Z-2465-2015 | Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile. Orthopedic Manual Surgical Instrument | Tornier has initiated a voluntary recall for the Salto Talaris Tibial Guide (part number MJU333) due to a complaint that occurred during physician training, that the guide cannot be assembled to the Salto Talaris Talar Pin Setting guide. This issue will cause the impossibility the time of putting the Talar pin in the guide. | Class II | Terminated | |
| Z-2315-2015 | Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic manual surgical instrument. | Recall for the Aequalis IM Nail instrumentation set (Tray Number 9020000) due to several reports that the mast of the targeting jig (Part Number 9020060) is separating from the jig boom. Separation will impact alignment and can affect the ability to fixate Aequalis IM Nail screws. | Class II | Terminated | |
| Z-0062-2015 | MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the outside. Used during procedures to clear away bone and cartilage within the desired implant area. | Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer | Class II | Terminated | |
| Z-2199-2013 | AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor. These products are contained within the Aequalis reversed II Instrument set tray no.YKAD83 and the Aequalis reversed fracture instrument set tray no.YKAD95. The items affected are MWD21, MWD023, MWD024 and MWD025. The impactor is an instrument used during shoulder arthroplasty; it is not implanted. The impactor is used to set the glenoid sphere, poly insert, spacer, and hemi adapter into place during surgery. The impactor is a two piece instrument which consists of a tip and a handle. The tip is made of plastic and metal that is pressed together for assembly. | Following the identification of the disassociation of an impactor tip during surgery, Tornier is initiating a voluntary recall of all lots of Aequalis Reversed II and Reversed Fracture impactors. Upon review of the event, Tornier determined that a redesign of the instrument was warranted. These products are contained within the Aequalis Revered II instrument set tray no YKAD83 and the Aequalis R | Class II | Terminated | |
| Z-0975-2013 | Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill Bit. Intended to stabilize and aid in fixation of fractures. | The firm was notified by a customer that there was a burr on the inside end of the drill bit resulting in the drill bit not fitting over the associated guide wire. | Class II | Terminated | |
| Z-0421-2012 | MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY. Product Usage: Variable Angle technology in MTP, TMT, MFT, MXL, DFX, and EDL plates are indicated for fractures, fusions and osteotomies for small bones in the hand, wrist, foot and ankle in both pediatric and adult patients. Variable Angle Technology in MXL and CLA plates are indicated for the fractures, fusions, and osteotomies of the clavicle and small bones in the hand, wrist, foot and ankle. | The firm discovered a testing protocol error, in both dynamic and static cantilever comparative testing, during the initial comparative testing. | Terminated | ||
| Z-3081-2011 | Mini MaxLock Extreme Plating System Case & Tray, Model Number(s): MXM-901, Product Usage: The Mini MaxLock Extreme Plating System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments. Surgical Case and Tray Delivery System used to house plating and screw orthopedic implant system and instrumentation. | The surgical tray does not meet our Instruction for Use (IFU) for dry time requirement. | Terminated | ||
| Z-3082-2011 | Latitude", Tige Humerale, Humeral Stem, Medium 77 mm, Humeral Stem Right, For Cemented use only, Sterile R, REF 0030402, Tornier In. Edina, MN 55435 USA. The Tornier In. Latitude Elbow Prosthesis is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis; correction of functional deformities; revision procedures where other treatments or devices have failed; treatment of fractures that are unmanageable using others techniques. The Tornier In. Latitude Elbow Prosthesis is intended for cemented use only. | Tornier has discovered that some models of the Tornier latitude Elbow Prosthesis (Small and Medium Humeral stems) were manufactured with a humeral screw that may not function as designed. | Terminated | ||
| Z-0468-2011 | CSS-059-40-4 Modified 4.0mm Modified Depth Gauge, Lot 0985011 | The print for modified CSS depth gauges has inaccurate definition of the etched screw length. The error results in a length reading that is longer (5 mm in the case of the 7.0 and 4mm in the cases of the 5.5 and 4.0) than the actual length of the buried guide wire segment and even longer (10 mm in the case of the 7.0 and 8mm in the cases of the 5.5 and 4.0) than the design intention readings. This | Terminated | ||
| Z-0467-2011 | CSS-059-55-4, Modified 5.5 mm Modified Depth Gauge, Lot 0985021 | The print for modified CSS depth gauges has inaccurate definition of the etched screw length. The error results in a length reading that is longer (5 mm in the case of the 7.0 and 4mm in the cases of the 5.5 and 4.0) than the actual length of the buried guide wire segment and even longer (10 mm in the case of the 7.0 and 8mm in the cases of the 5.5 and 4.0) than the design intention readings. This | Terminated |
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