Events

Recall of Device Recall DARTFIRE CANNULATED DRIVER STAR 8

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Wright Medical Technology 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
    56667
  • Event Risk Class
    Class 2
  • Event Number
    Z-2470-2010
  • Event Initiated Date
    2010-08-26
  • Event Date Posted
    2010-09-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94207
  • 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
    Screwdriver - Product Code HXX
  • Reason
    After autoclaving, the epoxy identifier (colored) band bled and there is concern that it may flake.
  • Action
    The firm initiated their recall the product by letter on 08/26/2010. The letters were addressed to distributors and hospital administrators with a fax back response form. Please contact Customer Service at 800-238-7117, if you have any questions.

Device

Device Recall DARTFIRE CANNULATED DRIVER STAR 8
  • Model / Serial
    Lot number 040754491
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    TX, PA, TN, VA, GA, and Spain
  • Product Description
    DRIVER STAR #8 CANNULATED DART-FIRE (TM), COMPRESSION SCREW, SIZE: #8, REF: DSDS-0008, 1 EACH, Rx ONLY, NON-STERILE, EC REP Wright Medical EMEA, Krijgsman 11, 1186 DM Amstelveen, The Netherlands, Wright Medical Technology, Inc., 5677 Airline Road, Arlington, TN 38002
  • Manufacturer
    Wright Medical Technology Inc

Manufacturer

Wright Medical Technology Inc
  • Manufacturer Address
    Wright Medical Technology Inc, 5677 Airline Rd, Arlington TN 38002-9501
  • Manufacturer Parent Company (2017)
    Wright Medical Group NV
  • Source
    USFDA