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Extremity Medical LLC recalls IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com; Customer Service: 888.499.0079 The X-Post Reamer i
Recalled December 5, 2012 · FDA recall Z-0438-2013 · Extremity Medical
Hazard
Product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was not performed prior to reaming. · FDA Class II
Units
156 units
Sold at
Worldwide Distribution - USA including FL, MA, NC, CA, MD, VA, IN, AL, NJ, AZ, OK, MT, NY, OH, IA, MI, TX, WI, GA, IL, TN and NE. Internationally to Switzerland.
Description
Product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was not performed prior to reaming.
Product
IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com; Customer Service: 888.499.0079 The X-Post Reamer is an accessory to the IO FiX Screw and Washer System that is used for reaming bone most common to orthopedic surgical procedures.
Manufacturer(s)
Extremity Medical LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →