Home / Recalls / Medical Devices
Extremity Medical LLC recalls IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com; Customer Service: 888.499.0079. Th
Recalled November 28, 2012 · FDA recall Z-0344-2013 · Extremity Medical
Hazard
Product Event Reports revealed that lag screw passes through washer (e.g. X-Post) intra-operatively. · FDA Class II
Units
120 Units
Sold at
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.
Description
Product Event Reports revealed that lag screw passes through washer (e.g. X-Post) intra-operatively.
Product
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.
Manufacturer(s)
Extremity Medical LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →