Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 7R 16MM, VE Model/Catalog Number: 342-16-707 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
This recall is currently active, issued August 8, 2025.
- Recall Initiated
- July 9, 2025
- Posted
- August 8, 2025
- Recall Number
- Z-2286-2025
- Quantity
- 20 implants
- Firm Location
- Austin, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Knee implants contain incorrect labeling
Distribution
US Nationwide distribution in the states of AL, AZ, CA, CO, FL, IA, IL, IN, KS, LA, NY, TN, TX.
Lot / Code Info
Lot Code: Item: 342-16-707 GTIN: 00888912167642 Lot: 161T1053
Root Cause
Labeling Change Control
Action Taken
On July 9, 2025 Enovis (Encore Medical, L.P.) issued a Urgent: Medical Device Recall notification to affected consignees via Email. Enovis asked consignees to take the following actions: 1. Review your stock for the products and lot numbers for the items to be returned. 2. Remove any indicated product from stock and quarantine. 3. This notice needs to be passed on to all those within your organization or to any organization where the product has been transferred. 4. Complete acknowledgement and response form and contact Customer Service at 1-800-456-8696 or through your regional email address, to place a replacement request. You will be provided with an RMA number and shipping label to return the affected product. 5. Return all devices (quantities listed above) using the RMA number and shipping label provided by Customer Service.