Hipstar V40 Femoral Stem Howemedica: Benoist Girard et Cie; 203 bd de la Grande Selle B.P.8; 14201 Herouville Saint Clai
FDA device recall Z-0227-2009 · posted 2008-10-31 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- The warning label "do not use with heads more than +10, offset" does not appear on 135 degree stem boxes. This warning is contained in the instructions for use.
- Action taken
- Recall notification letters were sent by Fed Ex on August 20, 2008 to Stryker branches/agencies and Hospital Risk Management departments. Letters to Branches stated the reason for the recall and the potential hazard. Both letters state that it is recommended that physicians follow patients in a manner that is consistent with a physicians routine standard of care for total hip arthroplasty. Contact Stryker Howmedica Osteonics Corp. at 1-201-831-5000 for assistance.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- LZO
- Quantity affected
- 77 units
- Distribution
- Nationwide
- Date initiated
- 2008-08-20
- Date posted
- 2008-10-31
- Date terminated
- 2009-06-01
- 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 |
|---|---|---|
| HIPSTAR FEMORAL STEM (K051223) | Stryker Orthopaedics | 2006-05-10 |