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U.S. Department of Health and Human Services

Class 2 Device Recall IO FIX IntraOsseous Fixation

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 Class 2 Device Recall IO FIX IntraOsseous Fixationsee related information
Date Initiated by FirmApril 13, 2011
Date PostedNovember 18, 2012
Recall Status1 Terminated 3 on March 21, 2013
Recall NumberZ-0344-2013
Recall Event ID 62916
510(K)NumberK101700 
Product Classification Screw, fixation, bone - Product Code HWC
ProductIO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com; Customer Service: 888.499.0079. The Extremity Medical Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small bones and joints of the foot, ankle, hand and wrist.
Code Information Product coding is listed as Catalog Number: Lot Number and are as follows: 118-30014:107509; 118-30016:107510; 118-30018:107511; 118-30020:107512; 118-30020:107513; 118-30022:107514; 118-30024:107515; 118-30026:107516; 118-40020:107457; 118-40025:107458; 118-40030;107529; 118-40030;107459; 118-40035:107460; 118-40040:107461; 118-40045:107462; 118-40050:107463; 118-40320:107613; 118-40325:107614; 118-40330:107615; 118-40330:107616; 118-40335:107617; 118-40340:107618; 118-40345:107619; 118-40350:107620.
Recalling Firm/
Manufacturer		 Extremity Medical LLC
300 Interpace Pkwy Ste 410A
Parsippany NJ 07054-1148
For Additional Information ContactMr. Jeffrey Zoleta
973-588-8980
Manufacturer Reason
for Recall		Product Event Reports revealed that lag screw passes through washer (e.g. X-Post) intra-operatively.
FDA Determined
Cause 2		Employee error
ActionExtremity Medical sent an e-mail notification (Extremity Medical- Sales Bulletin- IO Fix) dated April 13, 2011 to distributors notifying them of a change made to the 4.0 mm Lag Screw.
Quantity in Commerce120 Units
DistributionWorldwide Distribution-USA (nationwide) including the states FL, MA, NC, CA, MD, VA, IN, AL, NJ, AZ, OK, MT, NY, OH, IA, MI, TX, WI, GA, IL, TN and NE, and the country of 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.
510(K) Database510(K)s with Product Code = HWC
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