Brand Name: EMPOWR 3D KNEE TIBIAL INSERT — Class II medical device recall Z-2286-2025
Ongoing recall by Encore Medical, LP, reported 2025-08-20, distributed nationwide. Knee implants contain incorrect labeling (size and/or side incorrect)
| Recall number | Z-2286-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Encore Medical, LP, Austin, TX, United States |
| Recall initiated | 2025-07-09 |
| Classified | 2025-08-08 |
| Reported by FDA | 2025-08-20 |
| Distributed | Nationwide (US) |
| Quantity | 40 implants |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00888912167642 |
| Lot numbers | 161T1053, 161T1054 |
| Model numbers | 342-16-707 |
Product
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE Model/Catalog Number: 342-16-707 Product Description: Enovis knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use. While total knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.
Reason for recall
Knee implants contain incorrect labeling (size and/or side incorrect)
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-2286-2025. 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.