BEUDAMED
    FDA Recall Terminated

    LFIT Anatomic CoCr Femoral Heads, 6260-9-036

    Recall: Z-2292-2018 · Initiated May 22, 2018

    Recall

    Recall Number
    Z-2292-2018
    Event Number
    80059
    Firm
    Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    JDI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 22, 2018
    Terminated
    May 8, 2020
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2006

    Description

    LFIT Anatomic CoCr Femoral Heads, 6260-9-036

    Reason

    The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011.

    Action

    On May 22, 2018, Stryker issued a Product Safety Notification to its affected customers. The letter explained the issue and instructed customers to do the following: Follow-up Patients implanted with the Products should continue to be followed per the normal protocol established by his/her surgeon(s). There are no recommended changes to the frequency of the standard follow-up care protocol. Required actions 1. Hospitals/Surgeons: Please inform product users of this notification and forward this notice to all those individuals who need to be aware within your organization. Please also complete and sign the enclosed Business Reply Form and fax a copy to 888-861-8582 or email to Stericycle at strykerortho5940@stencycle com. Product is not required to be returned as part of this notification. if you have any questions, feel free to contact the firm at (201) 831-5151.

    Distribution

    Distributed nationwide. Foreign distribution to Australia, Canada, Chile, China, Brazil, France, Germany, India, Italy, Japan, Malaysia, Netherlands, New Zealand, Poland, Portugal, Romania, Singapore, South Africa, Spain, Sweden, Switzerland, and United Kingdom.