Class 2 Device Recall IO FiX XPost Reamer

• Date Initiated by Firm: April 25, 2011
• Date Posted: November 26, 2012
• Recall Status: 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 NJ 07054-1148
• For Additional Information Contact: 973-588-8980
• 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: 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.