BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0631-2014 · Reported January 15, 2014

    Enforcement

    Recall Number
    Z-0631-2014
    Event ID
    67131
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    The Anspach Effort, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    January 15, 2014
    Initiation Date
    June 11, 2012
    Classification Date
    January 6, 2014
    Termination Date
    April 18, 2016
    Address
    4500 Riverside Drive, Palm Beach Gardens, FL, 33410-4235, United States

    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).

    Code Info

    Serial # 1934, 3135, 50229989-3, and 31496704 (BLACKMAX-N) Serial # 80017906 (Foot Control)

    Distribution

    US Distribution: Maryland only.

    Quantity

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