Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE M...
FDA Recall #Z-2285-2025 — Class II — July 9, 2025
Product Description
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 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.
Reason for Recall
Knee implants contain incorrect labeling (size and/or side incorrect)
Recalling Firm
Encore Medical, LP — Austin, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
18 implants
Distribution
US Nationwide distribution in the states of AL, AZ, CA, CO, FL, IA, IL, IN, KS, LA, NY, TN, TX.
Code Information
Lot Code: Item: 341-16-704 GTIN: 00888912167116 Lot\s: 148T1057
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated