BEUDAMED
    FDA Enforcement Class II Terminated

    A&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S. For fracture fixation or reconstruction of the sternum.

    Recall: Z-0243-2020 · Reported November 6, 2019

    Enforcement

    Recall Number
    Z-0243-2020
    Event ID
    83942
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Alto Development Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 6, 2019
    Initiation Date
    September 10, 2019
    Classification Date
    October 29, 2019
    Termination Date
    May 12, 2020
    Address
    5206 Asbury Rd, Wall Township, NJ, 07727-3609, United States

    Description

    A&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S. For fracture fixation or reconstruction of the sternum.

    Reason

    Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensioner inoperable.

    Code Info

    327703, 327704, 330464, 344282

    Distribution

    Distributed to AL, CA, FL, GA, IL, LA, MO, OK, MS, NM, OK, SC, TX, UT, VT, WA, and WI.

    Quantity

    209 total