Recall Z-0723-2021 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Biomet, Inc.
Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for use in knee arthroplasty Item Number: 185422
| Date | Dec 1, 2020 |
| Status | Terminated |
| Reason | Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure |
| Root cause | Process control |
| Action | .Zimmer Biomet issued Urgent Medical Device Recall letter issued on 12/1/20 to distributors with direct sales and/or fielded inventory via email and traceable letter sent via FedEx. Hospitals with direct sales or current inventory will be notified via FedEx. Letter states reason for recall , health risk and action to take: Distributors esponsibilities include: locating and removing the product in their territory, as well as identifying hospitals who have previously used the product. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected |
| Quantity | 21 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the state of FL and the countries of Korea, Japan, Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093293 | VANGUARD 360 REVISION KNEE SYSTEM Biomet, Inc., Oct 22, 2010 |