—#66324

Product

Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 52 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: UH1-52-28 UHR BIPOLAR 28X52mm 1VKMED UH1-52-28 UHR BIPOLAR 28X52mm 53MMLD UH1-52-28 3KXMPD UH1-52-28 3KYMPD UH1-52-28 4KPMCA UH1-52-28 5JMMPD UH1-52-28 77MMLD UH1-52-28 8XRMPD UH1-52-28 D93MPD UH1-52-28 E9HMPD UH1-52-28 EDLMND UH1-52-28 EDRMND

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 #66324. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.