Recall Z-0482-2008
Stelkast Co · initiated October 5, 2007
Product
StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number SC2287-4-5, Size 4, Thickness 5 mm, StelKast, Murray, PA 15317
Codes / lots: Lot Numbers: 14894-122005, 16040-010906, 16054-031406, 17945-043007, and 17945-050107.
Reason for recall
The screws may fracture
FDA-determined cause: Device Design
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.
Details
- Recall number
- Z-0482-2008
- Initiated
- October 5, 2007
- Posted by FDA
- January 23, 2008
- Terminated
- January 23, 2008
- Product code
- JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Quantity
- 46 units
- Distribution
- Nationwide: shipped to medical facilities in IL, NC, PA, TN, TX, VA, and WV.
- Recalling firm
- Stelkast Co, Mcmurray, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0479-2008 | StelKast Proven Knee System - Tibial Half Block Augmentation and Screw. Part Number…The screws may fracture | 10/05/2007Terminated |
| Z-0480-2008 | StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number SC2287-2-5…The screws may fracture | 10/05/2007Terminated |
| Z-0481-2008 | StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number SC2287-3-5…The screws may fracture | 10/05/2007Terminated |
| Z-0483-2008 | StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number:…The screws may fracture | 10/05/2007Terminated |