BEUDAMED
    FDA Enforcement Class II Terminated

    CBS 7.5 tap, cannulated, AO, Item Number 503002041

    Recall: Z-1453-2019 · Reported May 29, 2019

    Enforcement

    Recall Number
    Z-1453-2019
    Event ID
    82642
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 29, 2019
    Initiation Date
    April 8, 2019
    Classification Date
    May 23, 2019
    Termination Date
    May 11, 2020
    Address
    Sulzerallee 8, N/A, Winterthur, N/A, N/A, Switzerland

    Description

    CBS 7.5 tap, cannulated, AO, Item Number 503002041

    Reason

    An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

    Code Info

    All items marked with "Normed" are affected

    Distribution

    The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

    Quantity

    N/A