FDA Device recall Z-1456-2024
ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System
- FDA Device
- Class II
- ongoing
- Published 2024-04-10
On 2024-04-10 the FDA classified a Class II recall of ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System by Depuy Orthopaedics, citing product incorrectly labelled.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1456-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-12 |
| Published | 2024-04-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Depuy Orthopaedics |
| Distribution | US |
Product
ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.
Reason
Product incorrectly labelled.
Identifiers
| code_info | Model No: 150621006; UDI-DI: 10603295507451; Lot JA06A0252. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1456-2024%22
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