BEUDAMED
    FDA Enforcement Class II Terminated

    Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder.

    Recall: Z-1523-2015 · Reported May 6, 2015

    Enforcement

    Recall Number
    Z-1523-2015
    Event ID
    70993
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Gmbh
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 6, 2015
    Initiation Date
    March 18, 2015
    Classification Date
    April 27, 2015
    Termination Date
    September 23, 2015
    Address
    Sulzer Allee 8, Winterthur, N/A, Switzerland

    Description

    Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder.

    Reason

    Complaints of difficulties to attach the Anatomical Shoulder Rasps (high resistance) or, once attached, due to difficulties to remove the handle (seizing up of the two components). This has the potential for delay in surgery.

    Code Info

    Lot Number(s): 13870129 & 13878179.

    Distribution

    Distributed to the states of IN, GA, WI, MO, PA, KS, TN, and NY.

    Quantity

    30 units