BEUDAMED
    FDA Enforcement Class II Terminated

    Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003.

    Recall: Z-0695-2013 · Reported January 23, 2013

    Enforcement

    Recall Number
    Z-0695-2013
    Event ID
    63863
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Howmedica Osteonics Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 23, 2013
    Initiation Date
    October 25, 2012
    Classification Date
    January 17, 2013
    Termination Date
    December 1, 2015
    Address
    325 Corporate Drive, N/A, Mahwah, NJ, 07430, United States

    Description

    Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003.

    Reason

    Two complaints have been filed where Hoffman LRF Wires have broken during load bearing application by patients.

    Code Info

    Catalog number 4933-1-001, Lot number Z02804, Z08348, Z08350, Z12549, Z16753. Catalog number 4933-1-002, Lot number Z08351, Z12554, Z16246, Z16752. Catalog number 4933-1-003 Lot Number Z08349, Z09344, Z12551, Z16996.

    Distribution

    Nationwide Distribution, including the states of PA, OH, NY, CA and IL.

    Quantity

    476 units