Recall Z-1257-2022 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Encore Medical, LP
DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708
| Date | May 5, 2022 |
| Status | Open, Classified |
| Reason | A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial insert. If implanted, a risk may include leaving debris in the joint space. |
| Root cause | Labeling mix-ups |
| Action | On 05/05/2022, recall notices were emailed to DJO Surgical Agents by Enovis. Notices state that DJO Surgical requires the following actions: 1) Pass on the recall notice within your organization or to any organization where the potentially affected product has been transferred. 2) Contact Customer Service at 1-800-456-8696 to place a replacement order and to receive an RMA number to return affected devices. 3) Customers with questions or issues can contact Customer Service. |
| Quantity | 20 |
| Distribution | U.S. Nationwide distribution in the states of TN, MN, IL, IN, SC, MS, CA, KS. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143242 | Rebel 3DKNEE System Encore Medical L.P., May 15, 2015 |