Hipstar V40 Femoral Stem-127 degrees; Catalog No: 7850-5-001, N degrees 3 high offset 31 mm;Sterile; IMPLANT SIZE 1, How
FDA device recall Z-0463-2008 · posted 2007-12-14 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Mis-labeled: The warning label "Do not use with heads more than +10mm offset" does not appear on 127 degree stem boxes.
- Action taken
- Urgent Product Correction/Recall notification letters were sent by Fed Ex return receipt on 9/28/07, requesting quarantine for Styker representatives to return or re-label.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- LPH
- Quantity affected
- 59
- Distribution
- Nationwide- USA including states of OR, AZ, NV, MI, AL, MI, FL, MN, and CA
- Date initiated
- 2007-09-28
- Date posted
- 2007-12-14
- Date terminated
- 2008-10-27
- 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 |
|---|---|---|
| MODIFICATION TO HIPSTAR FEMORAL STEM (K063822) | Stryker Orthopaedics | 2007-01-25 |