Recall Z-0081-2021 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Biomet, Inc.
Biomet Regenerex Primary Taper Cap Item Number 141269
| Date | Sep 4, 2020 |
| Status | Terminated |
| Reason | Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized |
| Root cause | Process change control |
| Action | Zimmer Biomet notified on 9/2/20 Distributors with direct sales and/or fielded inventory via email and traceable letter sent via FedEx. Hospitals with direct sales or current inventory, as well as hospitals that have consumed products in the past 12 months will be notified via FedEx. Surgeons that have consumed products with in the past 12 months notified via FedEx. 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 quaran |
| Quantity | US: 62 units; OUS: 176 units |
| Distribution | Nationwide Foreign: Canada, FINLAND, NETHERLANDS, UNITED KINGDOM |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080361 | REGENEREX TIBIAL COMPONENTS Biomet, Inc., Apr 21, 2008 |