Recall Z-0371-2010 ยท HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Stelkast Co
Stelkast Unicondylar Knee Femoral Component SC2462-1. Used for moderate joint impairment from painful arthritis (rheumatoid, osteo and/or post-traumatic; revision of failed unicompartmental knee implant or other procedure; and alternative to tibial osteotomy in patients with unicompartmental arthritis.
| Date | Nov 20, 2009 (initiated May 5, 2009) |
| Status | Terminated |
| Reason | incorrect size markings on component |
| Root cause | Nonconforming Material/Component |
| Action | The recalling firm telephoned the medical supply companies on 5/5-19/09 to inform them of the problem and the need to return the products. If there are questions regarding this issue, please call 1.888.273.1583. |
| Quantity | 20 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032824 | STELKAST UNICONDYLAR KNEE SYSTEM Stelkast Company, Nov 13, 2003 |