Z-0632-2022 Class II Terminated
FDA device recall Z-0632-2022 was initiated by DePuy Orthopaedics, Inc. on January 5, 2022 and is designated Class II. Reason for recall: May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur. The recall status is terminated (terminated December 22, 2023). Affected quantity: 3 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 16, 2022
- Initiation Date
- January 5, 2022
- Termination Date
- December 22, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
Product Description
ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154706001
Reason for Recall
May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur.
Distribution Pattern
US Nationwide distribution in the states of TN, TX.
Code Information
Lots: JJ3389 GTIN: 10603295382775