BEUDAMED
    FDA Enforcement Class II Terminated

    ARCH Leg Positioning System

    Recall: Z-0072-2022 · Reported October 13, 2021

    Enforcement

    Recall Number
    Z-0072-2022
    Event ID
    88636
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Innovative Orthopedic Technologies, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 13, 2021
    Initiation Date
    September 13, 2021
    Classification Date
    October 7, 2021
    Termination Date
    January 29, 2024
    Address
    1115 Highway 124, Winnie, TX, 77665, United States

    Description

    ARCH Leg Positioning System

    Reason

    Due to the holes not being bored to the specific diameter, the locking pins are unable to engage under a load.

    Code Info

    Model: 6813010 Serial Numbers: 6813010.0066; 6813010.0067; 6813010.0069; 6813010.0070; 6813010.0071; 6813010.0072; 6813010.0073; 6813010.0074; 6813010.0075; 6813010.0076;

    Distribution

    U.S. Nationwide distribution in the states of AL, AZ, FL, MI, MN, OK, SD, and TX.

    Quantity

    10 units