Recall Z-3249-2018 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Zimmer Biomet, Inc.
Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment, Model Number 185221 Intended for use in Total Knee Arthroplasty
| Date | Aug 2, 2018 |
| Status | Terminated |
| Reason | The implant only has one bolt in the sterile package but it should have had two. |
| Root cause | Under Investigation by firm |
| Action | The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL" notification letters dated 8/2/18 to customers on 8/2/18. The letters described the product, problem and actions to be taken. The letters instruct customers to perform the following actions: Risk Manager Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facil |
| Quantity | 16 |
| Distribution | Worldwide Distribution: US (nationwide) to the following US states: AZ, KS, NM, NV, and UT; and to countries of: Australia and 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 |