FDAFDA · Food and drugs·Recall number Z-2126-2025
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE Model/Catalog Number: 341-12-711 Software Version: NA 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. Component: NA
Published July 23, 2025 · Recall initiated: June 2, 2025
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
Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Encore Medical, LP
- Distributor
- U.S Distribution to states of: AZ, IA, ID, IL, IN, LA, MI, MO, MS, NE, NY, OK, OR, PR, SD, UT, VA, and WA
- Lot
- Lot Code: Item: 341-12-711 GTIN: 00888912166980 Lot: 115T1077
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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