Z-2285-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 20, 2025
- Initiation Date
- July 9, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18 implants
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)
Distribution Pattern
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