Ovation Hip Stem, REF 201-0104, Offset Stem Inserter Neutral, 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.
This recall has been terminated (originally issued March 16, 2011).
- Company
- Ortho Development Corporation
- Recall Initiated
- January 11, 2011
- Posted
- March 16, 2011
- Terminated
- November 4, 2011
- Recall Number
- Z-1673-2011
- Quantity
- 33 units
- Firm Location
- Draper, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Component of total hip arthroplasty may break during surgical procedure.
Distribution
Nationwide Distribution including AZ, CA, CO, FL, MI, NV, OR, and UT.
Lot / Code Info
All lots
Root Cause
Process design
Action Taken
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.
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