Home / Recalls / Wright Medical Technology, Inc. / Z-1366-2022

Z-1366-2022 Class II Ongoing

Recalled by Wright Medical Technology, Inc. — Memphis, TN

Recall Details

Product Type
Devices
Report Date
July 20, 2022
Initiation Date
June 14, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
231

Product Description

Wright EVOLVE TRIAD Plate Cutter, REF 49510120

Reason for Recall

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

Distribution Pattern

Nationwide and PR, and Australia, Canada, Chile, Colombia, Hong Kong, Puerto Rico

Code Information

Lot codes: 955401, 1168853, 1349302, 1956936, 2486857

Other recalls by Wright Medical Technology, Inc.

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  • Z-2105-2023 Class II — Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-ste (June 13, 2023)
  • Z-1467-2023 Class II — stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization an (April 10, 2023)
  • Z-1466-2023 Class II — stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization an (April 10, 2023)
  • Z-1170-2023 Class II — ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, Bone fixation devic (February 2, 2023)
  • Z-1169-2023 Class II — ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation devic (February 2, 2023)
  • Z-0140-2023 Class II — Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Ba (September 30, 2022)
  • Z-0139-2023 Class II — Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Ba (September 30, 2022)
  • Z-0005-2023 Class II — stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s E (August 3, 2022)
  • Z-0006-2023 Class II — stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s (August 3, 2022)