BEUDAMED
    FDA Recall Terminated

    ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm Product Usage: The OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system that offers both the fixation devices and instrument in one system. The insertion tool is used with a mallet to tap the tunnel sleeve implant into a counter-bored hole in the bone.

    Recall: Z-2560-2014 · Initiated July 25, 2014

    Recall

    Recall Number
    Z-2560-2014
    Event Number
    69050
    Firm
    OrthoPediatrics Corp
    FEI Number
    3006460162
    Product Code
    MBI
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 25, 2014
    Posted
    August 29, 2014
    Terminated
    May 19, 2015
    Address
    2850 Frontier Dr, Warsaw, IN, 46582-7001

    Description

    ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm Product Usage: The OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system that offers both the fixation devices and instrument in one system. The insertion tool is used with a mallet to tap the tunnel sleeve implant into a counter-bored hole in the bone.

    Reason

    Weld fractures on the Sleeve Installation Tool for ACL reconstruction system.

    Action

    OrthoPediatrics sent a Notification letter dated July 25, 2014 to all affected customers. The letter Identified the affected product, problem and actions to be taken. The letter informed customers to take immediate possession of all affected product within their control and at any of their health care facilities and immediately return the recalled device(s) to OrthoPediatrics Corp. This notice and the attached Reply Form should be forwarded if the affected product was further distributed. .

    Distribution

    US Nationwide Distribution.

    Quantity

    56 units