BEUDAMED
    FDA Recall Terminated

    Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutting and shaping bone.

    Recall: Z-0631-2014 · Initiated June 11, 2012

    Recall

    Recall Number
    Z-0631-2014
    Event Number
    67131
    Firm
    The Anspach Effort, Inc.
    FEI Number
    1045834
    Product Code
    GEY
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    June 11, 2012
    Posted
    January 6, 2014
    Terminated
    April 18, 2016
    Address
    4500 Riverside Drive, Palm Beach Gardens, FL, 33410-4235

    Description

    Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutting and shaping bone.

    Reason

    Anspach was contacted by a hospital to inform Anspach that a Blackmax motor had been used in a case where the patient was diagnosed with Creutzfeldt-Jacob Disease (CJD).

    Action

    none

    Distribution

    US Distribution: Maryland only.

    Quantity

    4 ( BLACKMAX-N) and 1 (Foot Control)