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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 Device Recall IO FiX XPost Reamersee related information
Date Initiated by FirmApril 25, 2011
Date PostedNovember 26, 2012
Recall Status1 Terminated 3 on March 21, 2013
Recall NumberZ-0438-2013
Recall Event ID 62918
Product Classification Reamer - Product Code HTO
ProductIO 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.
FEI Number 3007289093
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 2		Employee error
ActionExtremity 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 Commerce156 units
DistributionWorldwide 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 CycleTPLC 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.
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