Recall Z-1670-2011 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Ortho Development Corporation
Ovation Hip Stem, REF 201-0002, Hip Stem Inserter, Non-Sterile, Ortho Development, Draper, Utah 84020. The Ovation Hip System is intended for use in total hip arthroplasty. The hip stem inserter is an instrument used to seat the hip stem in the femur. There is a notch in the top of the hip stem, and the hip stem inserter has a corresponding tip at the end of the instrument. The tip of the inserter
| Date | Mar 16, 2011 (initiated Jan 11, 2011) |
| Status | Terminated |
| Reason | Component of total hip arthroplasty may break during surgical procedure. |
| Root cause | Process design |
| Action | Ortho Development Corporation notified Field representatives of the issue and conditions that could lead to failure by e-mail on December 14, 2010. Redesigned product is being produced for replacement. For questions regarding this recall call 801-619-3450. |
| Quantity | 33 units |
| Distribution | Nationwide Distribution including AZ, CA, CO, FL, MI, NV, OR, and UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062775 | EUROPEAN STYLE TAPER,PRESS-FIT HIP STEM Ortho Development Corp., Jan 16, 2007 |