Events

Recall of MaxTorque Cannulated Screw

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
    54540
  • Event Risk Class
    Class 2
  • Event Number
    Z-1250-2010
  • Event Initiated Date
    2009-04-07
  • Event Date Posted
    2010-04-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88678
  • 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
    screw, fixation, bone - Product Code HWC
  • Reason
    A pinhead sized disc was found in the cannulation of a msd-010-55-60s screw.
  • Action
    On April 7, 2009 the firm sent letters to their customers with detailed instructions on how to correct the problem. Pictures were included for clarification. For questions please contact either Jim Bragg via phone at 330-869-9562 ext 211 or Kristin Wolff at ext 209.

Device

MaxTorque Cannulated Screw
  • Model / Serial
    Model # MSD-010-55-060S
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Product was delivered to: CA, CO, GA, NM, NY, OH, VA & WA.
  • Product Description
    MaxTorque Cannulated Screw Model # MSD-010-55-060S
  • 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