BEUDAMED
    FDA Enforcement Class II Terminated

    OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an orthopedic implant system (bolt is used to attach the targeting arm to the intramedullary fixation rod) Part number: 01-1503-0032

    Recall: Z-0125-2020 · Reported October 23, 2019

    Enforcement

    Recall Number
    Z-0125-2020
    Event ID
    83767
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    OrthoPediatrics Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 23, 2019
    Initiation Date
    August 19, 2019
    Classification Date
    October 12, 2019
    Termination Date
    October 26, 2020
    Address
    2850 Frontier Dr, N/A, Warsaw, IN, 46582-7001, United States

    Description

    OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an orthopedic implant system (bolt is used to attach the targeting arm to the intramedullary fixation rod) Part number: 01-1503-0032

    Reason

    Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures

    Code Info

    Lot/serial number: 192432-B 192279-B 189808-A 187375-A 177577-A 183280-A 175221-A 174784-A UDI: 00841132149836

    Distribution

    Nationwide Foreign: Australia

    Quantity

    211 units