EMPOWR 3D Knee Tibial Insert — Class II medical device recall Z-0766-2025
Ongoing recall by Encore Medical, LP, reported 2025-01-01, distributed nationwide. 5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which may cause surg
| Recall number | Z-0766-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Encore Medical, LP, Austin, TX, United States |
| Recall initiated | 2024-12-18 |
| Classified | 2024-12-26 |
| Reported by FDA | 2025-01-01 |
| Distributed | Nationwide (US) |
| Quantity | 33 |
| UPC / GTIN / UDI-DI | 00888912167505, 00888912167628 |
| Model numbers | 342-14-703, 342-16-705 |
Product
EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703
Reason for recall
5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which may cause surgical delay to get a new product.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0766-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.