FDAHealthJanuary 5, 2026
Encore Medical, LP — EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
⚠️ 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.
Is this relevant to me?
- Geography
- US, TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CA
- Source agency
- FDA
- Category
- Health
- Published
- January 5, 2026
US: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CA
What's affected?
- Product
- EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
- Brand
- Encore Medical, LP
- Lot code
- 139T1075A
Additional details
UDI-DI: 00888912167529. Lot: 139T1075A. Expiration: 03-12-2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 19.
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