FDA-Device2013-07-17Class II
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.
Integra LifeSciences Corp.
Hazard
The firm has received numerous complaints of the cannulated screw driver tip breaking during surgery.
Sold states
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.
Affected count
154 screwdrivers were distributed; 67 screwdriver tips were distributed.
Manufactured in
311 Enterprise Dr, N/A, Plainsboro, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1685-2013Don't want to check this manually?
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