BEUDAMED
    FDA Recall Terminated

    MaxLock Screwdriver, part MXS-056. This is a surgical instrument used in conjunction with the MaxLock Plate and Screw System.

    Recall: Z-0598-06 · Initiated November 1, 2005

    Recall

    Recall Number
    Z-0598-06
    Event Number
    34498
    Firm
    Orthohelix Surgical Designs Inc
    FEI Number
    3000718467
    Product Code
    HRS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 1, 2005
    Posted
    March 9, 2006
    Terminated
    April 25, 2012
    Address
    1815 W Market Street, Suite 205, Akron, OH, 44313

    Description

    MaxLock Screwdriver, part MXS-056. This is a surgical instrument used in conjunction with the MaxLock Plate and Screw System.

    Reason

    Screwdriver pilot taper tip can break during surgery.

    Action

    Between 11/1 and 11/7/05, the recalling firm visited 12 of the consignees and collected the product, and phoned the other 2 consignees and requested return of the product.

    Distribution

    Ohio, Missouri, Texas, South Dakota, Colorado, New Jersey, Georgia, and Florida.

    Quantity

    14