Recall Z-2945-2011 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Biomet, Inc.
Vanguard PS Open Box Femoral 70 MM Left Interlock, " FOR CEMENTED USE ONLY" CO-CR-MO ALLOY. Biomet, Inc. A knee joint replacement prosthesis non-coated femoral indicated for cemented application only.
| Date | Aug 4, 2011 (initiated Jul 6, 2011) |
| Status | Terminated |
| Reason | The recalled device was manufactured with two distal pegs but package labeling indicates the device is pegless. |
| Root cause | Employee error |
| Action | Biomet Orthopedics sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letter to all affected customers. The letter included: reason for the recall, risks associated with use of the device, and alternate instructions for use of the recalled device. Customers are instructed to quarantine and return the devices, and a return form. For information or questions on this recall call Biomet at (574) 371-3756. |
| Quantity | 8 |
| Distribution | Worldwide Distribution: (USA) Nationwide including the states of NJ, PA, LA, SD, TX, and KS; and the country of The Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023546 | MAXIM ACCEL KNEE SYSTEM Biomet, Inc., Jan 17, 2003 |