—#66319

Product

Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 50 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: UH1-50-28 UHR BIPOLAR 28X50mm 0L7MHD UH1-50-28 UHR BIPOLAR 28X50mm 3JDMKA UH1-50-28 UHR BIPOLAR 28X50mm N4NMRA UH1-50-28 1E6MEA UH1-50-28 1EEMPD UH1-50-28 4E4MMD UH1-50-28 685MTA UH1-50-28 6W9MPD UH1-50-28 805MPD UH1-50-28 8HMMJA UH1-50-28 8XNMPD UH1-50-28 E9EMPD UH1-50-28 EKPMEA UH1-50-28 HHYMDA UH1-50-28 HLEMEA UH1-50-28 K5AMND

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 #66319. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.