Wright Medical Technology, Inc.

FDA Regulatory Profile

Summary

Total Recalls
78
510(k) Clearances
1
Inspections
32
Compliance Actions
0

Known Names

wright medical technology, wright medical technology inc

Recent Recalls

NumberClassProductDate
Z-1477-2024Class IIstryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplastyMarch 6, 2024
Z-2105-2023Class IIStryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.June 13, 2023
Z-1467-2023Class IIstryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixationApril 10, 2023
Z-1466-2023Class IIstryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixationApril 10, 2023
Z-1170-2023Class IIORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, Bone fixation deviceFebruary 2, 2023
Z-1169-2023Class IIORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation deviceFebruary 2, 2023
Z-0139-2023Class IIStryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, SSeptember 30, 2022
Z-0140-2023Class IIStryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, SSeptember 30, 2022
Z-0006-2023Class IIstryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s EVOLVE Proline PlusAugust 3, 2022
Z-0005-2023Class IIstryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE Proline Plus RAugust 3, 2022
Z-1567-2022Class IIStryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00, REF 4700020, Sterile.July 27, 2022
Z-1366-2022Class IIWright EVOLVE TRIAD Plate Cutter, REF 49510120June 14, 2022
Z-1291-2022Class IIStryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument June 2, 2022
Z-0853-2022Class IIEasyFuse Dynamic Compression System Instrument PackMarch 10, 2022
Z-0786-2022Class IIWright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, aFebruary 15, 2022
Z-0679-2022Class IIThe DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatibFebruary 9, 2022
Z-0392-2022Class IIStryker CLAW II ORTHOLOC 3DSi Plate, Hole Qty: 4, 30mm, REF 40240430.December 3, 2021
Z-0393-2022Class IIStryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm.December 3, 2021
Z-0401-2022Class IIWright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component oDecember 3, 2021
Z-0316-2022Class IIINBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUSNovember 4, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K221645PROstep(TM) MIS 5mm Chamfer Screw SystemFebruary 17, 2023