BEUDAMED
    FDA Enforcement Class II Terminated

    Mitek Screw and Washer Depth Gauge, Product Code 219024

    Recall: Z-0208-2019 · Reported October 31, 2018

    Enforcement

    Recall Number
    Z-0208-2019
    Event ID
    81059
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DePuy Mitek, Inc., a Johnson & Johnson Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 31, 2018
    Initiation Date
    August 30, 2018
    Classification Date
    October 23, 2018
    Termination Date
    June 5, 2020
    Address
    325 Paramount Dr, N/A, Raynham, MA, 02767-5199, United States

    Description

    Mitek Screw and Washer Depth Gauge, Product Code 219024

    Reason

    The device has an offset in the design that results in a reading approximately 3.2mm shorter than the actual length of the bone hole.

    Code Info

    UDI: 10886705005390; Lot Numbers: 0005178 1103107 0009101 1105132 0009181 1112106 0102157 1201104 0103045 950229 0205355 961232 0207451 970198 0208597 971229 0301615 980585 0302184 9809121 0303337 990765 0311333 C000007655 0311389 C000012527 0512552 C000020182 0605571 1000196842 0612501 1000415749 0707512 1000431580 0710501 1000661713 0801536 1001119996 0809117 1002144 0905130 1006113 0912100 1008120 1000064514 1103103

    Distribution

    US nationwide in the states of AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MI, MO, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, VT, WA, WI. The products were distributed to the following foreign countries: Australia, Canada, Chile, China, Chechnya, Denmark, Italy, Japan, Jordan, Netherlands, Poland, Slovenia, Sweden, Turkey, UK.

    Quantity

    401