Recalls / —
—#66320
Product
Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 51 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
- FDA product code
- KWL — Prosthesis, Hip, Hemi-, Femoral, Metal
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K800207
- Affected lot / code info
- Ref No: Description: Lot Code: UH1-51-28 UHR BIPOLAR 28X51mm AD0MLA UH1-51-28 UHR BIPOLAR 28X51mm D8XMLD UH1-51-28 0MNMJD UH1-51-28 763MMD UH1-51-28 7DJMND
Why it was recalled
Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.
Root cause (FDA determination)
Process control
Action the firm took
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.
Recalling firm
- Firm
- Stryker Howmedica Osteonics Corp.
- Address
- 325 Corporate Dr, Mahwah, New Jersey 07430-2002
Distribution
- Distribution pattern
- Worldwide Distribution - USA, Canada, China, India, Australia, Korea, Singapore, Taiwan, Sweden, Germany, Netherlands, France, Spain, Italy, Poland, South Africa, and England.
Timeline
- Recall initiated
- 2007-10-26
- Posted by FDA
- 2008-03-20
- Terminated
- 2010-01-27
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #66320. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.