BEUDAMED
    FDA Recall Terminated

    3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part number 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw. Used in pediatric orthopedics.

    Recall: Z-2796-2015 · Initiated July 28, 2015

    Recall

    Recall Number
    Z-2796-2015
    Event Number
    71933
    Firm
    OrthoPediatrics Corp
    FEI Number
    3006460162
    Product Code
    HRS
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    July 28, 2015
    Posted
    September 18, 2015
    Terminated
    March 17, 2016
    Address
    2850 Frontier Dr, Warsaw, IN, 46582-7001

    Description

    3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part number 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw. Used in pediatric orthopedics.

    Reason

    The 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw, Lot # 150192-J package may contain a different screw. The screw in the package is a 00-0903-2526, 3.5mm x 26mm, and is etched correctly.

    Action

    OrthoPediatrics has initiated a Voluntary RECALL of Part # 00-0903-2510, 3.5mm Non Locking Cortical Screw, Lot # 150192-J, initially by contacting customers via telephone, and then by e-mailing notification letters on 7/28/2015. Customers returned the 5 mislabled screws, which were repacked with correct labeling. All recall activities were complete as of 8/14/2015.

    Distribution

    Domestic: TN, IA Foreign: England VA/DOD: None

    Quantity

    5