EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705
This recall is currently active, issued October 12, 2023.
- Recall Initiated
- August 22, 2023
- Posted
- October 12, 2023
- Recall Number
- Z-0102-2024
- Quantity
- 36
- Firm Location
- Austin, TX
- Official Source
- View on FDA website ↗
Reason for Recall
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).
Distribution
US Nationwide distribution in the states of FL, CA, IN, HI, LA, MN, AZ, TX, NJ, PA, KS, TN, PR, SC, WA.
Lot / Code Info
UDI-DI: 00888912167321, Lot: 075T1167, Expiration: March 30, 2028
Root Cause
Labeling Change Control
Action Taken
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