BEUDAMED
    FDA Enforcement Class II Completed

    4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012

    Recall: Z-0959-2022 · Reported April 27, 2022

    Enforcement

    Recall Number
    Z-0959-2022
    Event ID
    89771
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Acumed LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 27, 2022
    Initiation Date
    March 9, 2022
    Classification Date
    April 20, 2022
    Address
    5885 NW Cornelius Pass Rd, Hillsboro, OR, 97124-9370, United States

    Description

    4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012

    Reason

    Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the indicated use. Remote possibility of resulting in a mal or nonunion of the bone fragments, iatrogenic fracture, joint impingement or damage, or soft tissue damage.

    Code Info

    All Batch numbers distributed between 22 AUG 2018 to 07 FEB 2022. UDI:10806378022876

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, Puerto Rico and the country of South Africa.

    Quantity

    506 unit