DJO Surgical EMPOWR 3D Knee Tibial Insert — Class II medical device recall Z-2103-2021
Ongoing recall by Encore Medical, LP, reported 2021-07-28, distributed nationwide. Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains 16mm knee pro
| Recall number | Z-2103-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Encore Medical, LP, Austin, TX, United States |
| Recall initiated | 2021-05-12 |
| Classified | 2021-07-20 |
| Reported by FDA | 2021-07-28 |
| Distributed | Nationwide (US) |
| Quantity | 10 units |
| UPC / GTIN / UDI-DI | 00888912166980 |
| Lot numbers | 115T1035 |
| Model numbers | 341-12-711 |
Product
DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00888912166980
Reason for recall
Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains 16mm knee prosthesis and 16mm knee prosthesis packaging contains 12 mm knee prosthesis.
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-2103-2021. 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.