Recall Z-0102-2024 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Encore Medical, LP
EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705
| Date | Oct 12, 2023 (initiated Aug 22, 2023) |
| Status | Open, Classified |
| Reason | 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). |
| Root cause | Labeling Change Control |
| Action | 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 |
| Quantity | 36 |
| Distribution | US Nationwide distribution in the states of FL, CA, IN, HI, LA, MN, AZ, TX, NJ, PA, KS, TN, PR, SC, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143242 | Rebel 3DKNEE System Encore Medical L.P., May 15, 2015 |