Simplex P with Tobramycin. Antibiotic PMMA Bone Cement.
FDA device recall Z-0467-2007 · posted 2007-01-10 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MBB
- Quantity affected
- 813 units
- Distribution
- Nationwide
- Date initiated
- 2006-11-07
- Date posted
- 2007-01-10
- Date terminated
- 2007-02-28
- Location
- Mahwah, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SURGICAL SIMPLEX P WITH TOBRAMYCIN (K014199) | Howmedica Osteonics Corp. | 2003-05-06 |