Events

Recall of Device Recall Modular Foot 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
    55256
  • Event Risk Class
    Class 2
  • Event Number
    Z-1784-2010
  • Event Initiated Date
    2010-03-23
  • Event Date Posted
    2010-06-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90423
  • 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
    On 3/9/10 it was discovered that the recalling firm packaged mft-021-35-24 screws from lot 0964092 as mft-021-35-22 lot 0964081.
  • Action
    OrthoHelix Surgical Designs, Inc. issued an "Important Field Correction Notice" dated March 23, 2010 via FedEx overnight. They instructed their customers to inventory their stock for affected product. All affected product will be replaced by the firm. For further information, contact OrthoHelix Surgical Designs, Inc. at 1-330-247-1444.

Device

Device Recall Modular Foot System
  • Model / Serial
    Lot Number: 0964081
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution -- AZ, CA, CO, FL, GA, ID, IL, MD, NC, NJ, NM, NY, OH, OK, PA, SC, TX, UT, VA and WA.
  • Product Description
    Modular Foot System 3.5mm x 22mm Locking Screw M/N: MFT-021-35-22. OrthoHelix Surgical Designs, Inc. Medina, OH 44256. || Intended as a guide to normal healing and are not intended to replace normal body structure or bear the weight of the body in the presence of incomplete bone healing.
  • 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