BEUDAMED
    FDA Enforcement Class II 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 · Reported September 30, 2015

    Enforcement

    Recall Number
    Z-2796-2015
    Event ID
    71933
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    OrthoPediatrics Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    September 30, 2015
    Initiation Date
    July 28, 2015
    Classification Date
    September 18, 2015
    Termination Date
    March 17, 2016
    Address
    2850 Frontier Dr, N/A, Warsaw, IN, 46582-7001, United States

    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.

    Code Info

    Part number 00-0903-2510, Lot number 150192-J

    Distribution

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

    Quantity

    5