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.
FDA Recall Z-1673-2011 · Posted 2011-03-16
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Recalling FirmOrtho Development Corporation
Recall StatusTerminated
Product CodeLZO
Date Initiated2011-01-11
Date Terminated2011-11-04
Product Quantity33 units
Reason for Recall
Component of total hip arthroplasty may break during surgical procedure.
Firm 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.
Root Cause
Process design
Distribution Pattern
Nationwide Distribution including AZ, CA, CO, FL, MI, NV, OR, and UT.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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