BEUDAMED
    FDA Recall 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 · Initiated August 19, 2019

    Recall

    Recall Number
    Z-0125-2020
    Event Number
    83767
    Firm
    OrthoPediatrics Corp
    FEI Number
    3006460162
    Product Code
    HSB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 19, 2019
    Terminated
    October 26, 2020
    Address
    2850 Frontier Dr, Warsaw, IN, 46582-7001

    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

    Action

    OrthoPediatrics, Inc. notified Distributors by letter via email on 8/19/19 , stating reason for recall, health risk and action to take: Distributors have been instructed to review their inventory and the inventory at their clinical sites to recover the product. Questions contact: Kriss Anderson, VP of Quality Systems and Regulatory Affairs, at OrthoPediatrics at [email protected] or 574-267-0897.

    Distribution

    Nationwide Foreign: Australia

    Quantity

    211 units