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Integra LifeSciences Corp. recalls Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N 1
Recalled July 17, 2013 · FDA recall Z-1685-2013 · Integra LifeSciences
Hazard
The firm has received numerous complaints of the cannulated screw driver tip breaking during surgery. · FDA Class II
Units
154 screwdrivers were distributed; 67 screwdriver tips were distributed.
Sold at
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.
Description
The firm has received numerous complaints of the cannulated screw driver tip breaking during surgery.
Product
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(s)
Integra LifeSciences Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →