FDAFDA · Food and drugs·Recall number Z-0766-2025
EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703
Published January 1, 2025 · Recall initiated: December 18, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which may cause surgical delay to get a new product.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Encore Medical, LP
- Distributor
- US Nationwide distribution in the states of VA, MN, TX, WI, IA, IL, IN, SC, NY, MD, CA, FL, AZ, WA.
- Lot
- REF/UDI-DI/Lot: 342-16-705/00888912167628/159T1086 342-14-703/00888912167505/137T1086
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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