Recall Z-1607-2024 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Biomet, Inc.
Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foil pouch with protective packaging in the form of a polyurethane bag, and sealed closed (inner barrier). The inner barrier is then placed into a PETG tray and sealed with Tyvek lid stock (outer barrier). The sealed double barrier system is placed into a paperboard carton with an I
| Date | Apr 22, 2024 (initiated Mar 13, 2024) |
| Status | Open, Classified |
| Reason | Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process. |
| Root cause | Process change control |
| Action | On March 27, 2024 URGENT MEDICAL DEVICE RECALL letters were via Email to Distributors and mail to customers. Customers were instructed to: 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 facility. 3. If the product has been further distributed, provide your customers with the field safety notice for hospitals and ensure documentation. 4. C |
| Quantity | 19 units (1 US, 18 OUS) |
| Distribution | Worldwide distribution - US Nationwide in the state of IN and the countries of Canada, India, Netherlands, and P.R. China. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050222 | VANGUARD ANTERIOR STABILIZED TIBIAL BEARINGS Biomet, Inc., Aug 16, 2005 |