FDA Device recall Z-0631-2022
ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Num…
- FDA Device
- Class II
- terminated
- Published 2022-02-16
On 2022-02-16 the FDA classified a Class II recall of ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Num… by Depuy Orthopaedics, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0631-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-01-05 |
| Published | 2022-02-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Depuy Orthopaedics |
| Distribution | US |
Product
ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154909003
Reason
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.
Identifiers
| code_info | Lots: JH9651, JH9649 GTIN: 10603295383178 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Other recalls by Depuy Orthopaedics
- ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System
FDA Device · Class II · 2024-04-10 · Depuy Orthopaedics - Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312
FDA Device · Class II · 2023-03-29 · Depuy Orthopaedics - Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507
FDA Device · Class II · 2023-03-29 · Depuy Orthopaedics - Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212
FDA Device · Class II · 2023-03-29 · Depuy Orthopaedics - Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226
FDA Device · Class II · 2023-03-29 · Depuy Orthopaedics
All Depuy Orthopaedics recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0631-2022%22
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