BEUDAMED
    FDA Recall Terminated

    VI DBL OFFST W/ LRG STPL, LT Nonsterile

    Recall: Z-2219-2014 · Initiated July 23, 2014

    Recall

    Recall Number
    Z-2219-2014
    Event Number
    68656
    Firm
    Zimmer, Inc.
    FEI Number
    1000220733
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 23, 2014
    Posted
    August 14, 2014
    Terminated
    September 15, 2015
    Address
    1800 W Center St, Warsaw, IN, 46580-2304

    Description

    VI DBL OFFST W/ LRG STPL, LT Nonsterile

    Reason

    The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

    Action

    On July 23, 2014, Zimmer issued recall notification to their consignees. Distributors were notified via electronic mail and courier. Recall notification included a description of the issue, affected product, possible risks to patient, and instructions for responding to the recall. Questions or concerns regarding the recall are directed to Zimmer customer call center @ 1-800-348-2759 M-F, 8am-8pm ET.

    Distribution

    Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.

    Quantity

    412 units