Device Recall Ovation Hip Stem, REF 2010103, Offset Stem Inserter LT, NonSterile, Ortho Development, Draper

All lots

Orthopedic Devices

2

Yes

Nationwide Distribution including AZ, CA, CO, FL, MI, NV, OR, and UT.

Ovation Hip Stem, REF 201-0103, Offset Stem Inserter LT, 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 is designed to fit into the notch of the hip stem, as a guide. Once this is inserted, the surgeon will tap on the opposite end of the inserter with a hammer to seat the press-fitted stem assembly.