Recall Z-0479-2008 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Stelkast Co
StelKast Proven Knee System - Tibial Half Block Augmentation and Screw. Part Number SC2287-1-5, Size 1, Thickness 5 mm, StelKast, Murray, PA 15317
| Date | Jan 23, 2008 (initiated Oct 5, 2007) |
| Status | Terminated |
| Reason | The screws may fracture |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 48 units |
| Distribution | Nationwide: shipped to medical facilities in IL, NC, PA, TN, TX, VA, and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051976 | PROVEN REVISION MODULAR TIBIAL TRAY Stelkast Company, Oct 17, 2005 |