Recall Z-1066-2013 ยท OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
Stelkast Co
Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459-52, and SC3460-52. Intended for use in reconstruction of the articulating surface of the acetabular portion of the hip.
| Date | Apr 7, 2013 (initiated Jan 24, 2013) |
| Status | Terminated |
| Reason | Firm was made aware of incidents relating to the difficulty of properly engaging and securing the Cross-Over 36mm liner into the Cross-Over shell. |
| Root cause | Device Design |
| Action | The firm initiated their recall of this product on January 24, 2013 by notifying their consignees by telephone informing them of the recall. |
| Quantity | 254 |
| Distribution | Nationwide Distribution including the states of NV, OK and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122773 | CROSS-OVER ACETABULAR SHELL & LINER Stelkast Company, Oct 9, 2012 |