StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number SC2287-4-5, Size 4, Thickness 5 mm, StelKas
FDA device recall Z-0482-2008 · posted 2008-01-23 · Terminated
Recall details
- Recalling firm
- Stelkast Co
- Reason for recall
- The screws may fracture
- Action taken
- The recalling firm telephoned their customers on 10/5/07 to inform them of the problem and the need to return the product. As a follow up to the telephone calls, the recalling firm issued a recall letter (Field Notification) on 10/9/07 via certified mail.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 46 units
- Distribution
- Nationwide: shipped to medical facilities in IL, NC, PA, TN, TX, VA, and WV.
- Date initiated
- 2007-10-05
- Date posted
- 2008-01-23
- Date terminated
- 2008-01-23
- 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 |
|---|---|---|
| PROVEN REVISION MODULAR TIBIAL TRAY (K051976) | Stelkast Company | 2005-10-17 |