—#66315

Product

Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 48 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: UH1-48-28 UHR BIPOLAR 28X48mm 0YNMMD UH1-48-28 UHR BIPOLAR 28X48mm 1A7MEA UH1-48-28 UHR BIPOLAR 28X48mm 611MMD UH1-48-28 UHR BIPOLAR 28X48mm EYRMLD UH1-48-28 UHR BIPOLAR 28X48mm MALMDA UH1-48-28 1A7MEA UH1-48-28 62JMKD UH1-48-28 803MPD UH1-48-28 A24MND

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 #66315. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.