Events

Recall of Device Recall Integra HalluFix cannulated screw driver and cannulated screwdriver tip

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Integra LifeSciences Corp..

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
    65503
  • Event Risk Class
    Class 2
  • Event Number
    Z-1685-2013
  • Event Initiated Date
    2013-02-01
  • Event Date Posted
    2013-07-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119360
  • 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, surgical - Product Code LRZ
  • Reason
    The firm has received numerous complaints of the cannulated screw driver tip breaking during surgery.
  • Action
    The firm sent recall notification letters to all consignees via traceable email or traceable fax on 02/01/13. The firm requested that the consignees fill out and return the Recall Acknowledgement and Return Form.

Device

Device Recall Integra HalluFix cannulated screw driver and cannulated screwdriver tip
  • Model / Serial
    The following lots of the cannulated screw driver (model number P/N 129733ND) were affected: D2ZG, D32L, D3HV, D3PG and E0U3.   The following lots of the cannulated screwdriver tip (model number P/N 129735ND) were affected: D2ZQ and D3EC.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, PA, RI, SC, TN, TX, UT, VA, and WA and the countries of Canada, Austria, Belgium, Switzerland, Czech Republic, Germany, Denmark, Spain, Finland, France, Ireland, Israel, Italy, Lebanon, Luxembourg, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sweden, United Arab Republic, United Kingdom, and South Africa.
  • Product Description
    Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N 129735ND). || Indicated for use in fixation of fractures, osteotomies and arthrodesis of the first metatarso-phalangeal joint.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.