BEUDAMED
    FDA Enforcement Class II Terminated

    OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.

    Recall: Z-2538-2020 · Reported July 15, 2020

    Enforcement

    Recall Number
    Z-2538-2020
    Event ID
    85837
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    OrthoPediatrics Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 15, 2020
    Initiation Date
    June 5, 2020
    Classification Date
    July 8, 2020
    Termination Date
    May 25, 2021
    Address
    2850 Frontier Dr, Warsaw, IN, 46582-7001, United States

    Description

    OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.

    Reason

    ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrect size. Product labeled as 10-1008-4070 was found to have 10-1008-4060 product in the package. Product labeled as 10-1008-4060 was found to have 10-1008-4070 product in the package.

    Code Info

    UDI: (01)00841132122198(17)240722(10)214320319A Lot# 214320319A

    Distribution

    US Nationwide distribution.

    Quantity

    9 units