Recall Z-0632-2008 ยท KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 48 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
| Date | Mar 20, 2008 (initiated Oct 26, 2007) |
| Status | Terminated |
| Reason | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 360 total |
| Distribution | Worldwide Distribution - USA, Canada, China, India, Australia, Korea, Singapore, Taiwan, Sweden, Germany, Netherlands, France, Spain, Italy, Poland, South Africa, and England. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K800207 | UHR UNIVERSAL6HIP REPLACEMENT Osteonics Corp., Feb 11, 1980 |