FDA-Device2012-12-05Class II
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.
Extremity Medical LLC
Hazard
Product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was not performed prior to reaming.
Sold states
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.
Affected count
156 units
Manufactured in
300 Interpace Pkwy Ste 410A, N/A, Parsippany, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0438-2013Don't want to check this manually?
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