Wright Medical Technology Inc
Arlington, TN, US
WRIGHT MEDICAL TECHNOLOGY, INC. appears in FDA device records in Arlington, TN. FDA records list one 510(k) clearance, no PMA records and 2 registered establishments. As of , FDA records show 140 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for Wright Medical Technology Inc in 2023.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2023 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1043534 | 1043534 | WRIGHT MEDICAL TECHNOLOGY, INC. | 11576 Memphis-Arlington Rd, Arlington, TN 38002 US | 2026 | and 83 more, listed in full below |
| 3010667733 | 3010667733 | WRIGHT MEDICAL TECHNOLOGY, INC. | 11500 Memphis Arlington Road, Arlington, TN 38002 US | 2026 | and 81 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
- HXNApplier, Cerclage
- GDOApplier, Surgical, Clip
- HWJAwl
- EMXBalloon, Epistaxis
- HTWBit, Drill
- GFGBit, Surgical
- GFABlade, Saw, General & Plastic Surgery, Surgical
- HTQBroach
- GECBrush, Scrub, Operating-Room
- FZOChisel, Surgical, Manual
- HXDClamp
- HWWCountersink
- HWRDriver, Prosthesis
- HTEElevator
- HWBExtractor
- HTDForceps
- HXEFork
- HTJGauge, Depth
- GDFGuide, Needle, Surgical
- FZXGuide, Surgical, Instrument
- HWAImpactor
- HWNInstrument, Compression
- HTZInstrument, Cutting, Orthopedic
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- EMFKnife, Surgical
- HXLMallet
- HWMOsteotome
- GFIOsteotome, Manual
- HWQPasser
- HTYPin, Fixation, Smooth
- HRSPlate, Fixation, Bone
- HTCPliers, Surgical
- HXBProbe
- HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- HXAProsthesis, Tendon, Passive
- HWPPunch, Femoral Neck
- HXOPusher, Socket
- HTRRasp
- GACRasp, Surgical, General & Plastic Surgery
- HTOReamer
- GADRetractor
- FNSRing Cutter
- HSBRod, Fixation, Intramedullary And Accessories
- HTXRongeur
- HSOSaw
- HRRScissors, Orthopedic, Surgical
- HWCScrew, Fixation, Bone
- HXRSpatula, Orthopedic
- HWDStarter, Bone Screw
- GATSuture, Nonabsorbable, Synthetic, Polyethylene
- FMFSyringe, Piston
- HXGTamp
- HWXTap, Bone
- FTYTape, Measuring, Rulers And Calipers
- HWTTemplate
- FSMTray, Surgical, Instrument
- HTNWasher, Bolt Nut
- HXCWrench
Recall records
Showing 25 of 140| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1477-2024 | stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty | Stryker has identified an issue that impacts specific lots of Infinity" Resection Guide Adjustment Blocks. The parts within these three lots were found to have been missing an internal screw in the finished instrument assembly. The missing screw is used to lockout the Medial/Lateral adjustment on the INFINITY Resection Adjustment Guide. | Class II | Open, Classified | |
| Z-2105-2023 | Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile. | The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby preventing pin placement through the pin holes. | Class II | Open, Classified | |
| Z-1467-2023 | stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation | Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts. | Class II | Open, Classified | |
| Z-1466-2023 | stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation | Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts. | Class II | Open, Classified | |
| Z-1170-2023 | ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, Bone fixation device | Stryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates within these two lots were found to have been comingled, resulting in the incorrect product in packages. Packaging for 402S0425 incorrectly contained 40241425, and vice versa. | Class II | Open, Classified | |
| Z-1169-2023 | ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation device | Stryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates within these two lots were found to have been comingled, resulting in the incorrect product in packages. Packaging for 402S0425 incorrectly contained 40241425, and vice versa. | Class II | Open, Classified | |
| Z-0140-2023 | Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4 | The tibial tray lock detail is oversized (larger than specification). | Class II | Open, Classified | |
| Z-0139-2023 | Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3 | The tibial tray lock detail is oversized (larger than specification). | Class II | Open, Classified | |
| Z-0006-2023 | stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It combines parts of two systems: EVOLVE Proline and EVOLVE TRIAD. | The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm +2 contains a size 9.5mm +4 stem, while the affected lot of EVOLVE Proline Stem 9.5mm +4 contains a size 7.5mm +2 stem. | Class II | Open, Classified | |
| Z-0005-2023 | stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It combines parts of two systems: EVOLVE Proline and EVOLVE TRIAD. | The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm +2 contains a size 9.5mm +4 stem, while the affected lot of EVOLVE Proline Stem 9.5mm +4 contains a size 7.5mm +2 stem. | Class II | Open, Classified | |
| Z-1567-2022 | Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00, REF 4700020, Sterile. | An incorrect sizing label was applied to the carton packaging. | Class II | Open, Classified | |
| Z-1366-2022 | Wright EVOLVE TRIAD Plate Cutter, REF 49510120 | The plate cutter is unable to meet sterilization requirements when it is sterilized in a double-wrapped configuration according to the Option 1 Steam Sterilization parameters detailed in instructions for use | Class II | Open, Classified | |
| Z-1291-2022 | Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle System. | The instrument is incorrectly color coded. | Class II | Open, Classified | |
| Z-0853-2022 | EasyFuse Dynamic Compression System Instrument Pack | The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking. | Class II | Terminated | |
| Z-0786-2022 | Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a component of the ORTHOLOC 2.0/2.4 Plate System. | An incorrect screw is packaged in the product, which contains a locking screw instead of a non-locking screw. | Class II | Terminated | |
| Z-0679-2022 | The DARCO Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plates use either 2.7mm or 3.5mm screws which intersect each other in pairs. The drill holes of the plates are aligned to assure the screws do not touch. The various plates model numbers differ from each other through among other things different curvatures, material strengths, lengths, number of plate holes and through different grades and bridge widths | Product was labelled with the incorrect manufacturing and distribution dates. | Class II | Terminated | |
| Z-0393-2022 | Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm. | The incorrect product is contained in the packaging. | Class II | Open, Classified | |
| Z-0392-2022 | Stryker CLAW II ORTHOLOC 3DSi Plate, Hole Qty: 4, 30mm, REF 40240430. | The incorrect product is contained in the packaging. | Class II | Open, Classified | |
| Z-0401-2022 | Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component of the CHARLOTTE Lisfranc Reconstruction System. | Incorrect product is contained in the packaging. | Class II | Open, Classified | |
| Z-0316-2022 | INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS | The package contents and package labeling do not match. | Class II | Terminated | |
| Z-0315-2022 | INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS | The package contents and package labeling do not match. | Class II | Terminated | |
| Z-2989-2020 | EVOLVE STEM 8.5MM Model # 496S085 | Lack of sterility assurance | Class II | Terminated | |
| Z-2797-2020 | Screw Removal Case Assembly, Part Number 1985BASE - Product Usage: The Wright Medical hardware removal kit is designed to facilitate removal of both plates and screws used in foot and ankle procedures. Along with a complete range of drivers, the kit also features driver handles and a range of k-wires to assist in removal of cannulated screws. This product is a multiple use, non-sterile instrument. | Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws. | Class II | Terminated | |
| Z-2796-2020 | Hardware removal kit, Part Number 1985KIT1 - Product Usage: The Wright Medical hardware removal kit is designed to facilitate removal of both plates and screws used in foot and ankle procedures. Along with a complete range of drivers, the kit also features driver handles and a range of k-wires to assist in removal of cannulated screws. This product is a multiple use, non-sterile instrument. | Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws. | Class II | Terminated | |
| Z-1924-2020 | WRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left, REF 2000252902 - Product Usage: is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint. | One lot of INBONE Tibial Trays is missing the plasma coating. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain