Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, ...
FDA Recall #Z-2126-2025 — Class II — June 2, 2025
Product Description
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
Reason for Recall
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.
Recalling Firm
Encore Medical, LP — Austin, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
20
Distribution
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
Code Information
Lot Code: Item: 341-12-711 GTIN: 00888912166980 Lot: 115T1077
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated