EMPOWR 3D Knee Tibial Insert (Unknown) – Surgical Parts Swap (2023)
Swapped medical parts can cause potential surgical planning confusion.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705
Lot Codes / Batch Numbers
UDI-DI: 00888912167321, Lot: 075T1167, Expiration: March 30, 2028
Products Sold
UDI-DI: 00888912167321, Lot: 075T1167, Expiration: March 30, 2028
A medical device manufacturer is recalling EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705 due to Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeo. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee).
Recommended Action
Per FDA guidance
On 8/22/23, recall notices were emailed to agents who were asked to do the following: 1) Complete acknowledgement and response form and contact Customer Service at 1-800-456-8696 to place a replacement order and receive an RMA number. 2) The notice needs to be passed on to all those within your organization or to any organization where the potentially affected product has been transferred. If you have any questions, email 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