FDA Medical Device Recalls (openFDA)
Ortho Development Corporation: 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.
- Recall number
- Z-1673-2011
- Recalling firm
- Ortho Development Corporation
- Product
- 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.
- Status
- Terminated
- Initiated
- 2011-01-11
- Posted
- 2011-03-16
- Terminated
- 2011-11-04
- 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.
- Lot, serial or model codes
- All lots
- 510(k) numbers
- ["K062775"]
- PMA numbers
- not on file
- Product code
- LZO
- Firm FEI
- 3017298928
- Firm city
- Draper
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28