Events

Recall of Device Recall Extremity Medical Disposable Instrument 1.6 mm Guidewire

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

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
    64330
  • Event Risk Class
    Class 2
  • Event Number
    Z-0952-2013
  • Event Initiated Date
    2013-01-10
  • Event Date Posted
    2013-03-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115841
  • 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
    Passer, wire, orthopedic - Product Code HXI
  • Reason
    The 1.6 mm guidewire is undersized up to 2 mm in length. when used with the depth gauge, the measurement reading will not correspond with the desired screw length. the selected screw size based on the depth gauge reading will be about 2 mm longer than intended.
  • Action
    Extremity Medical sent an "URGENT: FIELD SAFETY NOTICE" dated January 10, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Response Form was included for customers to complete and return. Contact Customer Service at 1 (973) 588-8980 for questions regarding this notice. On April 10, 2013, Extremity sent notifications to their customers at the surgeon level. They were asked to complete the attached product field action response form.

Device

Device Recall Extremity Medical Disposable Instrument 1.6 mm Guidewire
  • Model / Serial
    Catalog Number 101-00006; Lot Number 00921538.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA including the states of Florida, Pennsylvania, New Hampshire, Oklahoma, California, Maryland, Arizona, Ohio, North Carolina, Texas, Virginia, Illinois, New York and Tennessee, and the countries of Australia, Belgium, Israel, Netherlands and United Kingdom.
  • Product Description
    Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire - Reference Number 101-00006 - Non-Sterile. Contained in Extremity Medical Surgical Kits including CompressX, Hallu.X, IO Fix and XMCP. Used in the selection of screw size when used with appropriate depth gauge.
  • Manufacturer
    Extremity Medical LLC

Manufacturer

Extremity Medical LLC
  • Manufacturer Address
    Extremity Medical LLC, 300 Interpace Pkwy Ste 410A, Parsippany NJ 07054-1148
  • Manufacturer Parent Company (2017)
    Extremity Medical Llc
  • Source
    USFDA