EMPOWER 3D Knee Tibial Insert — Class II medical device recall Z-0126-2023
Ongoing recall by Encore Medical, LP, reported 2022-11-02, distributed nationwide. Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which m
| Recall number | Z-0126-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Encore Medical, LP, Austin, TX, United States |
| Recall initiated | 2022-08-12 |
| Classified | 2022-10-21 |
| Reported by FDA | 2022-11-02 |
| Distributed | Nationwide (US) |
| Quantity | 18 |
| UPC / GTIN / UDI-DI | 00888912167055 |
| Lot numbers | 00888912167055/132T1085 |
| Model numbers | 341-14-708 |
Product
EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component.
Reason for recall
Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for surgeries, which may cause delays in surgery.
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-0126-2023. 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.