Events

Recall of Intraosseous Fixation 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
    64485
  • Event Risk Class
    Class 2
  • Event Number
    Z-0975-2013
  • Event Initiated Date
    2012-10-30
  • Event Date Posted
    2013-03-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-12-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116246
  • 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
    Bit, drill - Product Code HTW
  • Reason
    The firm was notified by a customer that there was a burr on the inside end of the drill bit resulting in the drill bit not fitting over the associated guide wire.
  • Action
    OrthoHelix sent a "FIELD REMOVAL NOTIFICATION" letter dated November 7, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 330-247-1444 for questions concerning this notice.

Device

Intraosseous Fixation System
  • Model / Serial
    Part #: IFS-072-17-C, Lot #: 2399041; Part #: IFS-72-20-C, Lot #: 2399051 & Lot #: 2399051R and Part #: IFS-072-25-C, Lot #: 2399061.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including the states of CA, CO, IL, MI, MD, NC, NM, OH, OK, PA, SD, TX, UT, VA, WA and WI.
  • Product Description
    Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill Bit. || Intended to stabilize and aid in fixation of fractures.
  • Manufacturer
    Orthohelix Surgical Designs Inc

Manufacturer

Orthohelix Surgical Designs Inc
  • Manufacturer Address
    Orthohelix Surgical Designs Inc, 1065 Medina Rd Ste 500, Medina OH 44256-5376
  • Manufacturer Parent Company (2017)
    Wright Medical Group NV
  • Source
    USFDA