Recall Z-0496-2019 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Zimmer Biomet, Inc.
Vanguard Knee System -PS Open Box Femoral Right, 65 mm Item Number:183108
| Date | Oct 22, 2018 |
| Status | Terminated |
| Reason | Label on the outer carton or the patient labels does not match label on the inner sterile packaging |
| Root cause | Labeling mix-ups |
| Action | Zimmer issued recall letter on 10/22/18 via email and FedEx. Acountts requested to immediately locate and quarantine affected product in your inventory. Return affected product from your distributorship and from affected hospitals. Complete Inventory Return Certification Form. uestions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. |
| Quantity | 8 units |
| Distribution | AR, MO, MN, NJ, NY, OH, MN , NJ, VA |
| FDA record | Open on fda.gov |