EMPOWR 3D Knee Tibial Insert (Unknown) – Surgical Kit Mismatch (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
Lot Codes / Batch Numbers
UDI-DI: 00888912167338. Lot: 076T1273A
Products Sold
UDI-DI: 00888912167338. Lot: 076T1273A
A medical device manufacturer is recalling EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706 due to Knee insert package may contain an acetabular system, which may cause surgical delay to get a new product.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Knee insert package may contain an acetabular system, which may cause surgical delay to get a new product.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026