Stelkast Dual Taper Wedge Pressed Fit Femoral Component. Hip Prosthesis, Part number SC1439
FDA device recall Z-0664-2009 · posted 2009-01-28 · Terminated
Recall details
- Recalling firm
- Stelkast Co
- Reason for recall
- Sterility may be compromised due to breach in packaging.
- Action taken
- On 10/7/08, Stelkast telephoned the two customers of the problem and the need to return the products.
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- LWJ
- Quantity affected
- 6 units
- Distribution
- USA distribution to dealers in TX and WV.
- Date initiated
- 2008-10-07
- Date posted
- 2009-01-28
- Date terminated
- 2009-04-01
- Location
- Mcmurray, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENT (K953268) | Stelkast Company | 1996-01-17 |