Ovation Hip Stem, REF 201-0104, Offset Stem Inserter Neutral, Non-Sterile, Ortho Development, Draper, Utah 84020. The Ov
FDA device recall Z-1673-2011 · posted 2011-03-16 · Terminated
Recall details
- Recalling firm
- Ortho Development Corporation
- Reason for recall
- Component of total hip arthroplasty may break during surgical procedure.
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- LZO
- Quantity affected
- 33 units
- Distribution
- Nationwide Distribution including AZ, CA, CO, FL, MI, NV, OR, and UT.
- Date initiated
- 2011-01-11
- Date posted
- 2011-03-16
- Date terminated
- 2011-11-04
- Location
- Draper, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EUROPEAN STYLE TAPER,PRESS-FIT HIP STEM (K062775) | Ortho Development Corp. | 2007-01-16 |