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U.S. Department of Health and Human Services

Enforcement Report - Week of December 5, 2012

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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
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.

Product Detail

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