BEUDAMED
    FDA Recall Terminated

    OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sleeve Installation Tool Set , Part 01-1008-0040/0047, 6mm; 6.5mm, 7mm, 7.5mm, 8mm, 8.5mm, 9mm, and 10mm. Used with ACL reconstruction system associated surgery.

    Recall: Z-0579-2014 · Initiated November 7, 2013

    Recall

    Recall Number
    Z-0579-2014
    Event Number
    67003
    Firm
    OrthoPediatrics Corp
    FEI Number
    3006460162
    Product Code
    MBI
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    November 7, 2013
    Posted
    December 26, 2013
    Terminated
    May 9, 2014
    Address
    2850 Frontier Dr, Warsaw, IN, 46582-7001

    Description

    OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sleeve Installation Tool Set , Part 01-1008-0040/0047, 6mm; 6.5mm, 7mm, 7.5mm, 8mm, 8.5mm, 9mm, and 10mm. Used with ACL reconstruction system associated surgery.

    Reason

    Part # 01-1008-0040/0047, ACL Sleeve Installation/ Insertion Tool, shipped November 4, 2013 - November 6, 2013 may be etched with the wrong size.

    Action

    November 7, 2013 all consignees were notified of the Urgent Device recall via telephone calls and E-mail messages describing the product and reason for the recall,. The notice included directions to identify and quarantine the recalled devices returning product to OrthoPediatrics with completed return form to OrthoPediatrics via mail, email or courier service, or by photographing with a smart phone and emailing to [email protected] or by answering the recall specific questionsin an email to [email protected]

    Distribution

    Nationwide Distribution including the states of CA, KY, OH, RI, and TN.

    Quantity

    40