Omnifit HA Hip Stem These devices are modular components of a total hip system. These femoral stems are intended for use
FDA device recall Z-0891-2009 · posted 2009-01-26 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices.
- Action taken
- Recall notification letters were sent via Federal Express on November 21, 2008 to Stryker Branches/Agencies, Hospital Risk Management, Chief of Orthopaedics and Surgeon. The letters explained the problem and indicated that there are no risk factors. Contact Stryker Orthopaedics for additional information at 1-201-831-5718.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- MEH
- Quantity affected
- 322 total units - all types
- Distribution
- Nationwide. OUS: Australia, Canada, Japan, Argentina, Brazil, Germany, Spain, Columbia, Guatemala and Sweden.
- Date initiated
- 2008-11-13
- Date posted
- 2009-01-26
- Date terminated
- 2010-01-20
- Location
- Mahwah, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OSTEONICS OMNIFIT HA HIP STEM SERIES, OSTEONICS SECUR-FIT HA HIP STEM SERIES, OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS (K982032) | Osteonics Corp. | 1998-07-09 |