FDA Device recall Z-0761-2025
EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
- FDA Device
- Class II
- ongoing
- Published 2025-01-01
On 2025-01-01 the FDA classified a Class II recall of EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706 by Encore Medical, citing knee insert package may contain an acetabular system, which may cause surgical delay to get a new product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0761-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-12-10 |
| Published | 2025-01-01 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Encore Medical |
| Distribution | US |
Product
EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
Reason
Knee insert package may contain an acetabular system, which may cause surgical delay to get a new product.
Identifiers
| code_info | UDI-DI: 00888912167338. Lot: 076T1273A |
|---|
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-0761-2025%22
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