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U.S. Department of Health and Human Services

Class 2 Device Recall IO FiX XPost Reamer

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 Class 2 Recall
IO FiX XPost Reamer
see related information
Date Posted November 26, 2012
Recall Status1 Terminated on March 21, 2013
Recall Number Z-0438-2013
Recall Event ID 62918
Product Classification Reamer - Product Code HTO
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
Manufacturer Reason
for Recall
Product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was not performed prior to reaming.
FDA Determined
Cause 2
TRAINING: Employee Error
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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