Recall Z-1073-2009 ยท LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Stelkast Co
Dual Taper Wedge Pressed Fit Femoral Component. The Dual Taper Wedge is a single use device intended for pressed fit reconstruciton of the femoral portion of severely disable and/or very painful hip joints resulting from osteoarthritis, rheumatoid arthritis, traumatic, arthritis or avascular necrosis where radiographic evidence of sufficient sound bone to seat the prosthesis is present.
| Date | Mar 31, 2009 (initiated Oct 31, 2008) |
| Status | Terminated |
| Reason | A possible breach of the sterile barrier packaging (Tyvek pouch). |
| Root cause | Packaging |
| Action | The recalling firm telephoned the distributors to inform them of the problem and the need to return the product. |
| Quantity | 187 units |
| Distribution | Nationwide Distribution -- states of NC, 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 |