Recall Z-0467-2007 ยท MBB Bone Cement, Antibiotic
Stryker Howmedica Osteonics Corp.
Simplex P with Tobramycin. Antibiotic PMMA Bone Cement.
| Date | Jan 10, 2007 (initiated Nov 7, 2006) |
| Status | Terminated |
| Reason | The expiration date on the external label is incorrect in that it does not identify the earliest expiration date of the subcomponents. The External label provides for an incorrect longer expiration date than the actual subcomponents will support. |
| Root cause | Other |
| Action | A recall notification was sent by Federal Express on 11/7/06. The firm will follow-up with telephone calls and follow-up letters as necessary. |
| Quantity | 813 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K014199 | SURGICAL SIMPLEX P WITH TOBRAMYCIN Howmedica Osteonics Corp., May 6, 2003 |