FDA-Device2012-11-28Class II
IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com; Customer Service: 888.499.0079. The Extremity Medical Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small bones and joints of the foot, ankle, hand and wrist.
Extremity Medical LLC
Hazard
Product Event Reports revealed that lag screw passes through washer (e.g. X-Post) intra-operatively.
Sold states
Worldwide Distribution-USA (nationwide) including the states FL, MA, NC, CA, MD, VA, IN, AL, NJ, AZ, OK, MT, NY, OH, IA, MI, TX, WI, GA, IL, TN and NE, and the country of Switzerland.
Affected count
120 Units
Manufactured in
300 Interpace Pkwy Ste 410A, N/A, Parsippany, NJ, United States
Products
IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com; Customer Service: 888.499.0079. The Extremity Medical Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small bones and joints of the foot, ankle, hand and wrist.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0344-2013Don't want to check this manually?
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