Recall Z-1798-2015 ยท HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Biomet, Inc.
Vanguard M Unicondylar Tibial Trial For use during knee joint replacement.
| Date | Jun 15, 2015 (initiated Apr 22, 2015) |
| Status | Terminated |
| Reason | The Left and Right orientation of the trial was incorrectly etched on one side. When the instrument is rotated about the axis of the handle 180 degrees to view the other side, the etch on the handle now shows R on the same side as the keel marked LM and the L on the same side as the keel marked RM. This is incorrect. Please note that the keel is not etched on this side by design. |
| Root cause | Process control |
| Action | On 4/22/2015, URGENT MEDICAL DEVICE RECALL NOTICE notifications, dated April 22, 2015 were sent to the affected distributors with instructions for returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers are required to immediately locate and remove the affected product from circulation, follow the instructions on the "Response Form," and e-mail a copy of the completed form to the designated e-mail address prior to retu |
| Quantity | 27 |
| Distribution | Worldwide Distribution -- US, including the state of IL, NJ, Canada, Netherlands, and Chile. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042093 | VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS Biomet, Inc., Nov 1, 2004 |