Recall Z-0496-05 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Stelkast Co
Proven Porous CR Femur. Implantable orthopedic device
| Date | Feb 3, 2005 (initiated Sep 24, 2004) |
| Status | Terminated |
| Reason | Sterility may be compromised. The inner pouch of the implant packaging was sticking out beyond the seal of the outer pouch |
| Root cause | Other |
| Action | The recalling firm telephoned their customers 9/24/04 to inform them of the problem and the need to return the product. As a follow up to the telephone call, the recalling firm sent fax notifications to their customers. The medical supply companies were instructed to contact their customers. |
| Quantity | 105 units |
| Distribution | The product was shipped to medical supply companies in CA, MO, NC, and WV and sales representatives in AZ , NC and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002281 | STELKAST PROVEN KNEE SYSTEM Stelkast Company, Aug 17, 2000 |