Events

Recall of IO FiX XPost Reamer

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
    62918
  • Event Risk Class
    Class 2
  • Event Number
    Z-0438-2013
  • Event Initiated Date
    2011-04-25
  • Event Date Posted
    2012-11-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112035
  • 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
    Reamer - Product Code HTO
  • Reason
    Product event reports revealed a broken reamer experienced intra-operatively. pre-drilling was not performed prior to reaming.
  • Action
    Extremity Medical sent a notification by e-mail that describes the "Slight modification to the Surgical Technique" on April 25, 2011. For questions regarading this recall call 973-588-8980.

Device

IO FiX XPost Reamer
  • Model / Serial
    Product coding is listed as Catalog Number: Lot Number and are as follows: 118-0005:126564; 118-30016:127375; 118-30018:AP6A08; 118-30020:AP6A07.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including FL, MA, NC, CA, MD, VA, IN, AL, NJ, AZ, OK, MT, NY, OH, IA, MI, TX, WI, GA, IL, TN and NE. Internationally to Switzerland.
  • Product Description
    IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com; Customer Service: 888.499.0079 || The X-Post Reamer is an accessory to the IO FiX Screw and Washer System that is used for reaming bone most common to orthopedic surgical procedures.
  • 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