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.
Reported: July 17, 2013 Initiated: February 1, 2013 #Z-1685-2013
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.
Reason for Recall
The firm has received numerous complaints of the cannulated screw driver tip breaking during surgery.
Details
- Recalling Firm
- Integra LifeSciences Corp.
- Units Affected
- 154 screwdrivers were distributed; 67 screwdriver tips were distributed.
- 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.
- Location
- Plainsboro, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Integra LifeSciences Corp.. Units affected: 154 screwdrivers were distributed; 67 screwdriver tips were distributed..
Why was this product recalled? ▼
The firm has received numerous complaints of the cannulated screw driver tip breaking during surgery.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 17, 2013. Severity: Moderate. Recall number: Z-1685-2013.
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