EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703
This recall is currently active, issued December 26, 2024.
- Recall Initiated
- December 18, 2024
- Posted
- December 26, 2024
- Recall Number
- Z-0766-2025
- Quantity
- 33
- Firm Location
- Austin, TX
- Official Source
- View on FDA website ↗
Reason for Recall
5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which may cause surgical delay to get a new product.
Distribution
US Nationwide distribution in the states of VA, MN, TX, WI, IA, IL, IN, SC, NY, MD, CA, FL, AZ, WA.
Lot / Code Info
REF/UDI-DI/Lot: 342-16-705/00888912167628/159T1086 342-14-703/00888912167505/137T1086
Root Cause
Labeling Change Control
Action Taken
On 12/18/2024, recall notices were emailed to consignees who were asked to do the following: 1. This notice needs to be passed on to all those within your organization or to any organization where the product has been transferred. 2. Review your stock for the products and lot numbers for the items to be returned. 3. Return all devices (quantities listed above) using the RMA number and shipping label provided by Customer Service. 4. Complete and return the acknowledgement and response form via email to Lesli.Helmick@enovis.com If you have questions contact the firm at productsafety@enovis.com