Dual Taper Wedge Pressed Fit Femoral Component. The Dual Taper Wedge is a single use device intended for pressed fit rec
FDA device recall Z-1073-2009 · posted 2009-03-31 · Terminated
Recall details
- Recalling firm
- Stelkast Co
- Reason for recall
- A possible breach of the sterile barrier packaging (Tyvek pouch).
- Action taken
- The recalling firm telephoned the distributors to inform them of the problem and the need to return the product.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- LWJ
- Quantity affected
- 187 units
- Distribution
- Nationwide Distribution -- states of NC, TX, and WV.
- Date initiated
- 2008-10-31
- Date posted
- 2009-03-31
- Date terminated
- 2009-04-14
- 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 |