BEUDAMED
    FDA Enforcement Class II Terminated

    Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (product code HSB). The attachment bolts are one component of the surgical instruments within the system.

    Recall: Z-0219-2020 · Reported November 6, 2019

    Enforcement

    Recall Number
    Z-0219-2020
    Event ID
    83884
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    OrthoPediatrics Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 6, 2019
    Initiation Date
    August 19, 2019
    Classification Date
    October 25, 2019
    Termination Date
    April 30, 2020
    Address
    2850 Frontier Dr, Warsaw, IN, 46582-7001, United States

    Description

    Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (product code HSB). The attachment bolts are one component of the surgical instruments within the system.

    Reason

    Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.

    Code Info

    175221-A 177577-A 183280-A 187375-A 189808-A 192279-B 192432-B 198082-C

    Distribution

    Worldwide distributions - US Nationwide distributions including states of AL, AZ, CA, CO, FL, GA, IA, IL, IN, KY, MD, MI, NC, NY, OH, OK, TN, TX, UT, VA, WA, and WI. Country of Australia.

    Quantity

    969 total