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U.S. Department of Health and Human Services

Enforcement Report - Week of December 5, 2012

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Product Detail

Product Description 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.
Recall Number Z-0438-2013
Classification Class II
Code Info 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.
Product Distributed Qty 156 units
Reason For Recall Product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was not performed prior to reaming.

Event Detail

Event Id 62918
Product Type Devices
Status Ongoing
Recalling Firm Extremity Medical LLC
City Parsippany
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-04-25
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern 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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