Recall Z-0664-2009 ยท LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Stelkast Co
Stelkast Dual Taper Wedge Pressed Fit Femoral Component. Hip Prosthesis, Part number SC1439
| Date | Jan 28, 2009 (initiated Oct 7, 2008) |
| Status | Terminated |
| Reason | Sterility may be compromised due to breach in packaging. |
| Root cause | Package design/selection |
| Action | On 10/7/08, Stelkast telephoned the two customers of the problem and the need to return the products. |
| Quantity | 6 units |
| Distribution | USA distribution to dealers in TX and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K953268 | DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENT Stelkast Company, Jan 17, 1996 |