Citation TMZF HA Hip Stem Right (Femoral Hip Prosthesis) Catalog No. 6265-5116
FDA device recall Z-0349-03 · posted 2002-12-19 · Terminated
Recall details
- Recalling firm
- Howmedica Osteonics Corp
- Reason for recall
- Hip Stem Fractures in the neck area.
- Action taken
- Letters to Surgeons was sent certified mail on Nov. 4, 2002. Letters to Howmedica agents send on Nov. 12, 2002.
- Root cause
- Other
- Status
- Terminated
- Product code
- MEH
- Quantity affected
- 16
- Distribution
- Product was distributed to hospitals and Howmedica Branch reps throughout the US.
- Date initiated
- 2002-11-12
- Date posted
- 2002-12-19
- Date terminated
- 2003-04-04
- Location
- Rutherford, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CITATION TMZF HA STEM (K993768) | Howmedica Osteonics Corp. | 2000-01-21 |