Recall Z-1187-2023 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Encore Medical, LP
EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM, REF: 346-22-706; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 7, 22MM, REF: 346-22-707; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 8, 22MM, REF: 346-22-708; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 9, 22MM, REF: 346-22-709; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 10, 22MM, REF: 346-22-710; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 11, 22MM, REF: 346-22-711; EMPOWR VVC KNEE TIBIAL INS
| Date | Feb 27, 2023 (initiated Dec 22, 2022) |
| Status | Open, Classified |
| Reason | Tibial insert implant large boxes were labeled small and the small boxes were labeled large. If the incorrect labeling is identified this could lead to surgical delay and if the surgeon does not recognize the size discrepancy between the insert label and the pin label, the surgeon may implant the incorrect pin size. |
| Root cause | Labeling Change Control |
| Action | On 12/22/22 recall notices were emailed to surgical agents who were asked to do the following: 1) Pass on the notice to all those within their organization or to any organization where potentially affected products have been transferred. 2) Return affected products. 3) Complete and return the Consignee Reconciliation notice. The following number was provided: Customer Service, 1-800-456-8696 On 2/8/23 recall notices were emailed with an expanded scope. |
| Quantity | 216 |
| Distribution | US: MN, IL, IN, NY, FL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180930 | EMPOWR VVC TIBIAL INSERT Encore Medical L.P., Jul 9, 2018 |