Recall Z-1289-03 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Biomet, Inc.
Stanmore modular hip system; Stanmore CoCr femoral size 4 straight stem; part 164254
| Date | Sep 24, 2003 (initiated Jun 18, 2003) |
| Status | Terminated |
| Reason | The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place. |
| Root cause | Other |
| Action | Distributors were sent a letter on June 18, 2003 via FedEx. This mailing contained labels and the distributors were instructed to affix the label to the inventory consigned to hospitals within their territory. |
| Quantity | 35 |
| Distribution | United States |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K911684 | BIOMET COBALT-CHROME FEMORAL COMPONENTS Biomet, Inc., Jun 27, 1991 |