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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
IO FiX X-Post Reamer		see related information
Date Posted November 26, 2012
Recall Number Z-0438-2013
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.
Code Information Product coding is listed as Catalog Number: Lot Number and are as follows: 118-0005:126564; 118-30016:127375; 118-30018:AP6A08; 118-30020:AP6A07.
Recalling Firm/
Manufacturer		 Extremity Medical LLC
300 Interpace Pkwy Ste 410A
Parsippany, New Jersey 07054-1148
Reason for
Recall		 Product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was not performed prior to reaming.
Action Extremity Medical sent a notification by e-mail that describes the "Slight modification to the Surgical Technique" on April 25, 2011. For questions regarading this recall call 973-588-8980.
Quantity in Commerce 156 units
Distribution 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.
 
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