FDA Device recall Z-0102-2024
EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705
- FDA Device
- Class II
- ongoing
- Published 2023-10-18
On 2023-10-18 the FDA classified a Class II recall of EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705 by Encore Medical, citing knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct pro….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0102-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-08-22 |
| Published | 2023-10-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Encore Medical |
| Distribution | US |
Product
EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705
Reason
Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee).
Identifiers
| code_info | UDI-DI: 00888912167321, Lot: 075T1167, Expiration: March 30, 2028 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0102-2024%22
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