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 INSERT, SIZE 5 BRIDGE UP, 22MM, REF: 346-22-755; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6 BRIDGE DOWN, 22M Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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.

Distribution

As reported by FDA

FL, IL, IN, MN, NY