EMPOWR 3D Knee Tibial Insert — Class II medical device recall Z-0102-2024
Ongoing recall by Encore Medical, LP, reported 2023-10-18, distributed nationwide. Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed withi
| Recall number | Z-0102-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Encore Medical, LP, Austin, TX, United States |
| Recall initiated | 2023-08-22 |
| Classified | 2023-10-12 |
| Reported by FDA | 2023-10-18 |
| Distributed | Nationwide (US) |
| Quantity | 36 |
| UPC / GTIN / UDI-DI | 00888912167321 |
| Lot numbers | 075T1167 |
| Model numbers | 342-10-705 |
| Expiration dates | 2028-03-30 |
Product
EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705
Reason for recall
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).
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-0102-2024. 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.