BEUDAMED
    FDA Recall Terminated

    Stryker Instruments 7.0mm XX Coarse Round Diamond Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-13-170.

    Recall: Z-1013-2008 · Initiated January 10, 2008

    Recall

    Recall Number
    Z-1013-2008
    Event Number
    46341
    Firm
    Stryker Instruments Div. of Stryker Corporation
    FEI Number
    1811755
    Product Code
    HBE
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    January 10, 2008
    Posted
    April 22, 2008
    Terminated
    December 1, 2009
    Address
    4100 E. Milham Ave., Portage, MI, 49002-9704

    Description

    Stryker Instruments 7.0mm XX Coarse Round Diamond Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-13-170.

    Reason

    Lack of assurance of sterility.

    Action

    Stryker sent a Medical Device Recall Notification letter dated 1/10/08 to consignees. The letter instructed them to check their facility for product, cease using it, and to return the product using a mailing label provided. International subsidiaries were notified via email.

    Distribution

    Worldwide Distribution - USA, Australia, Brazil, Canada, England, France, Germany, Hong Kong, India, Italy, Japan, Mexico, the Netherlands, New Zealand, Portugal, Saudi Arabia, Poland, Romania, South Africa, Spain, Sweden, Switzerland and United Arab Emirates.

    Quantity

    10,588 of all products