Events

Recall of Modified 4.0mm Modified Depth Gauge for MaxTorque Screw System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Orthohelix Surgical Designs Inc.

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
    57095
  • Event Risk Class
    Class 2
  • Event Number
    Z-0468-2011
  • Event Initiated Date
    2010-10-15
  • Event Date Posted
    2010-11-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95385
  • 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
    Tap, bone - Product Code HWX
  • Reason
    The print for modified css depth gauges has inaccurate definition of the etched screw length. the error results in a length reading that is longer (5 mm in the case of the 7.0 and 4mm in the cases of the 5.5 and 4.0) than the actual length of the buried guide wire segment and even longer (10 mm in the case of the 7.0 and 8mm in the cases of the 5.5 and 4.0) than the design intention readings. this.
  • Action
    OrthoHelix issued an Important Recall Notice letter dated October 15, 2010 to their customers, identifying the affected products. Customers were requested to immediately return the afected devices. OrthoHelix can be contacted at 330 247-1444 concerning this recall.

Device

Modified 4.0mm Modified Depth Gauge for MaxTorque Screw System
  • Model / Serial
    CSS-059-40-4 Modified 4.0mm Modified Depth Gauge, Lot 0985011
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: to the states of GA and MO.
  • Product Description
    CSS-059-40-4 Modified 4.0mm Modified Depth Gauge, Lot 0985011
  • Manufacturer
    Orthohelix Surgical Designs Inc

Manufacturer

Orthohelix Surgical Designs Inc
  • Manufacturer Address
    Orthohelix Surgical Designs Inc, 1065 Medina Rd., Suite 500, Medina OH 44256
  • Manufacturer Parent Company (2017)
    Wright Medical Group NV
  • Source
    USFDA