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Class 2 Device Recall IO FiX XPost Reamer |
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Date Initiated by Firm |
April 25, 2011 |
Date Posted |
November 26, 2012 |
Recall Status1 |
Terminated 3 on March 21, 2013 |
Recall Number |
Z-0438-2013 |
Recall Event ID |
62918 |
Product Classification |
Reamer - Product Code HTO
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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
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For Additional Information Contact |
973-588-8980
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Manufacturer Reason for Recall |
Product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was not performed prior to reaming.
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FDA Determined Cause 2 |
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
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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.
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