BEUDAMED
    FDA Recall Terminated

    V-TEK", micro-countersink, round shaft, Item Number 28.66.112

    Recall: Z-1464-2019 · Initiated April 8, 2019

    Recall

    Recall Number
    Z-1464-2019
    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

    V-TEK", micro-countersink, round shaft, Item Number 28.66.112

    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.