BEUDAMED
    FDA Enforcement Class II Terminated

    Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-1102-1000) is utilized to allow the surgeon to apply a recommended tension to the band and hold it in place during spine manipulation and set screw tightening.

    Recall: Z-2321-2017 · Reported June 14, 2017

    Enforcement

    Recall Number
    Z-2321-2017
    Event ID
    77270
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    OrthoPediatrics Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    June 14, 2017
    Initiation Date
    April 24, 2017
    Classification Date
    June 8, 2017
    Termination Date
    September 18, 2017
    Address
    2850 Frontier Dr, N/A, Warsaw, IN, 46582-7001, United States

    Description

    Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-1102-1000) is utilized to allow the surgeon to apply a recommended tension to the band and hold it in place during spine manipulation and set screw tightening.

    Reason

    Over-tensioning of the band resulting in damage to the band causing it to rupture

    Code Info

    All lots Product Number: 01-1102-1000

    Distribution

    Worldwide Distribution-US distribution to: MO, NY, KY, FL, NC and OH; and countries of: AUSTRALIA, FRANCE and SPAIN.

    Quantity

    82