Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 47 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics
FDA device recall Z-0629-2008 · posted 2008-03-20 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.
- Action taken
- Stryker sent Urgent Product Hold letters to US branches/agencies and hospitals on October 26, 2007 advising them to quarantine the product from these lots, and Urgent Product Recall letters on November 2, 2007 advising them to return the devices to Stryker. International distributors were sent an advisory on November 6, 2007.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KWL
- Quantity affected
- 360 total
- Distribution
- Worldwide Distribution - USA, Canada, China, India, Australia, Korea, Singapore, Taiwan, Sweden, Germany, Netherlands, France, Spain, Italy, Poland, South Africa, and England.
- Date initiated
- 2007-10-26
- Date posted
- 2008-03-20
- Date terminated
- 2010-01-27
- 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 |
|---|---|---|
| UHR UNIVERSAL6HIP REPLACEMENT (K800207) | Osteonics Corp. | 1980-02-11 |