Encore Medical, LP recalls EMPOWR 3D Knee Tibial Insert 5R 14MM
- Recalling company
- Encore Medical, LP
- Product
- EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
- Reason
- 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jan 5, 2026
- Reported
- Feb 11, 2026
- Distribution
- US: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CA
- Status
- Ongoing
- Quantity
- 19
- Lot / codes
- UDI-DI: 00888912167529. Lot: 139T1075A. Expiration: 03-12-2026
- Company location
- Austin, TX
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1233-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1233-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.