Recall Z-0123-2008 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Biomet, Inc.
Biomet Orthopedics, Vanguard PS Open Box Femoral, 67.5 mm Left-Interlok, For Cemented Use Only, CO-CR-MO Alloy, REF 183130, Knee Prosthesis Component, Biomet Orthopedics, Inc., Warsaw, IN 46581
| Date | Dec 5, 2007 (initiated Aug 31, 2007) |
| Status | Terminated |
| Reason | Mislabeled as to size; labeled as 67.5 mm, actually contains 62.5 mm size femoral component. |
| Root cause | Packaging process control |
| Action | Biomet notified consignees via letter dated 8/31/07, titled Urgent Medical Device Recall Notice to immediately discontinue use of the product and to return units to Biomet. |
| Quantity | 16 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023546 | MAXIM ACCEL KNEE SYSTEM Biomet, Inc., Jan 17, 2003 |