Recall Z-2289-2018 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Zimmer Biomet, Inc.
Vanguard Complete Knee System; E1 Vanguard PS Tibial Bearing; Model Numbers EP-183664, EP-183642 Product Usage: The product is intended for use in knee joint replacement arthroplasties.
| Date | Jun 4, 2018 (initiated May 24, 2018) |
| Status | Terminated |
| Reason | Two lots of tibial bearings were commingled. There is a possibility that a 14mm tibial bearing is packaged in a box labeled as 12 mm tibial bearing and vice versa. This may lead to extension of surgery to find another implant. |
| Root cause | Under Investigation by firm |
| Action | On May 24, 2018, Zimmer Biomet issued an Urgent Medical Device Recall letter to its affected consignees via email and FedEx. The letter informed customers of the product commingling issue. Customers were instructed to take the following actions: Distributors: 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete Attachment 1 Inventory Return Certifi |
| Quantity | 48 |
| Distribution | Distributed to accounts in CA, CT, GA, IA, IN, LA, MA, MD, MN, MS, NJ, OH, PA, TN, TX, UT, VA, WI. Foreign distribution to Taiwan, Japan, and the Netherlands. |
| FDA record | Open on fda.gov |