BEUDAMED
    FDA Recall Terminated

    CBS 4.0 countersink, cannulated, 30mm stop, AO, Item Number 503004353

    Recall: Z-1459-2019 · Initiated April 8, 2019

    Recall

    Recall Number
    Z-1459-2019
    Event Number
    82642
    Firm
    Zimmer GmbH Sulzerallee 8 Winterthur Switzerland
    FEI Number
    3005233524
    Product Code
    HWW
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    April 8, 2019
    Terminated
    May 11, 2020

    Description

    CBS 4.0 countersink, cannulated, 30mm stop, AO, Item Number 503004353

    Reason

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

    Action

    Urgent Medical Device Recall notification letters dated 4/8/19 were sent to customers.

    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.