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Terminated

UStryker Orthopaedics; HR Universal Bipolar Component; 26 x 54 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430

FDA Recall Z-0643-2008 · Posted 2008-03-20

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeKWL
Date Initiated2007-10-26
Date Terminated2010-01-27
Product Quantity360 total

Reason for Recall

Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.

Firm Action

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.

Root Cause

Process control

Distribution Pattern

Worldwide Distribution - USA, Canada, China, India, Australia, Korea, Singapore, Taiwan, Sweden, Germany, Netherlands, France, Spain, Italy, Poland, South Africa, and England.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K800207UHR UNIVERSAL6HIP REPLACEMENTOsteonics Corp. · 1980-02-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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