Recall Z-2204-2010 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Biomet, Inc.
Biomet Vanguard CR femoral 57.5 mm left interlok, Sterile, REF 183022, Knee prosthesis component.
| Date | Aug 10, 2010 (initiated Apr 20, 2010) |
| Status | Terminated |
| Reason | A knee implant labeled as left was opened and the package actually contained a right knee implant. |
| Root cause | Process control |
| Action | On 4/13, 14 and 15 Biomet made phone calls to the consignees to inform them of the recall. The firm sent Urgent Medical Device Recall Notices dated 4/20/2010. The customers were instructed to immediately locate the recalled products and return them to the manufacturer. |
| Quantity | 5 |
| Distribution | 1 unit in US. 3 units in Biomet distributor inventory, 1 unit in Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023546 | MAXIM ACCEL KNEE SYSTEM Biomet, Inc., Jan 17, 2003 |