EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
This recall is currently active, issued December 23, 2024.
- Recall Initiated
- December 10, 2024
- Posted
- December 23, 2024
- Recall Number
- Z-0761-2025
- Quantity
- 9
- Firm Location
- Austin, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Knee insert package may contain an acetabular system, which may cause surgical delay to get a new product.
Distribution
US Nationwide distribution in the states of IN, KS, CA, FL, NY, TX, AL, WA.
Lot / Code Info
UDI-DI: 00888912167338. Lot: 076T1273A
Root Cause
Labeling Change Control
Action Taken
On 12/10/2024, recall notices were emailed to customers asking them 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