—#66307

Product

Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 45 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: UH1-45-26 UHR BIPOLAR 26X45mm 2RJMPA UH1-45-26 UHR BIPOLAR 26X45mm 2RMMPA UH1-45-26 UHR BIPOLAR 26X45mm K15MPA UH1-45-26 3KDMMD UH1-45-26 3KLMPD UH1-45-26 4JHMPD UH1-45-26 637MKD UH1-45-26 75TMMD UH1-45-26 E94MPD UH1-45-26 EDAMND UH1-45-26 EDDMND UH1-45-26 K4VMND

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 #66307. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.