Recall Z-0032-2009 ยท JDC Prosthesis, Elbow, Constrained, Cemented
Biomet, Inc.
Biomet brand Discovery Elbow, 3 mm x 75 mm right ulna with bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For cemented use only, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 114813. The product intended use is for Orthopedic implant.
| Date | Oct 3, 2008 (initiated May 23, 2008) |
| Status | Terminated |
| Reason | The component in the package is not the correct size. |
| Root cause | Packaging process control |
| Action | Consignees were notified by letter dated May 28, 2008 to locate and return the recalled lots. Contact Biomet Orthopedics at 1-800-348-9500, ext. 3983 for assistance. |
| Quantity | 6 |
| Distribution | USA--California, Illinois, Indiana, Massachusetts, Ohio Puerto Rico, and Canada, OUS: Germany and Great Britain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013042 | DISCOVERY ELBOW Biomet Orthopedics, Inc., Oct 10, 2001 |