Events

Recall of Response BandLoc 5.5/6.0 Tensioner Instrument

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by OrthoPediatrics Corp.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77270
  • Event Risk Class
    Class 2
  • Event Number
    Z-2321-2017
  • Event Initiated Date
    2017-04-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155589
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Bone fixation cerclage, sublaminar - Product Code OWI
  • Reason
    Over-tensioning of the band resulting in damage to the band causing it to rupture.
  • Action
    The firm, OrthoPediatrics Corp., contacted each distributor/consignee via phone on 4/24/2017, regarding the recall. The phone call informed Consignees of issue and actions to be taken. The consignees were instructed to return of devices in their control were issued; cease further distribution of the product and quarantine it. The firm state that product will be distributed after Rework to new revision. If you have any questions, contact V.P. Regulatory Affairs, at (574) 268-6379 or email: mfox@orthopediatrics.com.

Device

Response BandLoc 5.5/6.0 Tensioner Instrument
  • Model / Serial
    All lots Product Number: 01-1102-1000
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution-US distribution to: MO, NY, KY, FL, NC and OH; and countries of: AUSTRALIA, FRANCE and SPAIN.
  • Product 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.
  • Manufacturer
    OrthoPediatrics Corp

Manufacturer

OrthoPediatrics Corp
  • Manufacturer Address
    OrthoPediatrics Corp, 2850 Frontier Dr, Warsaw IN 46582-7001
  • Manufacturer Parent Company (2017)
    Orthopediatrics Corp
  • Source
    USFDA