Events

Recall of Device Recall Extremity Medical LLC

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
    63805
  • Event Risk Class
    Class 2
  • Event Number
    Z-0752-2013
  • Event Initiated Date
    2012-03-22
  • Event Date Posted
    2013-01-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-06-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114794
  • 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
    Lag screw measurement is short (approximately 5 mm) when using current screw measuring device (p/n 101-00010) per the io fix surgical technique rev c. which can lead to possible inappropriate implant size selection (e.G. shorter screw size selected).
  • Action
    Extremity Medical LLC sent e-mail notification dated March 22, 2012, to all affected customers. The email identified the product the problem and the action to be taken by the customers. The email includes a buleeting which informes the customer that an upgrade to the existing instrumentation is being released. The upgrade will replace the existing gauge. Updated pdf versions of the technique guide are also included. Customers are instructed to return the recalled device after swapping out the recalled device with the replacement unit. Customers will be contacted by Extremity and Sales Reps should contact their principal. For further questions please call (973) 588-8980.

Device

Device Recall Extremity Medical LLC
  • Model / Serial
    Catalog Number 101-00010 Lot number  AP3V12 AP4E01 AP4N04 AP5E25 AP6A44 AP6E42 AP6L14 AP6M17 AP6T08
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- Nationwide Distribution including the states of AR, AZ, CA, FL, GA, IL, IN, MD, MT, NC, NE, NH, NJ, NY, OH, PA, TN, TX, WI and WA.
  • Product Description
    Extremity Medical, IO FiX System Accessory. Catalog Number 101-00010. || This screw measuring device is an accessory to the IO FiX Screw and Washer System that is used to measure the length of the screw by placing the depth gauge over the guidewire and down to the bone. Orthopedic device.
  • 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