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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 Fixation see related information
Date Initiated by Firm April 13, 2011
Date Posted November 18, 2012
Recall Status1 Terminated 3 on March 21, 2013
Recall Number Z-0344-2013
Recall Event ID 62916
510(K)Number K101700  
Product Classification Screw, fixation, bone - Product Code HWC
Product IO 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 Contact Mr. 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
Action Extremity 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 Commerce 120 Units
Distribution Worldwide 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 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.
510(K) Database 510(K)s with Product Code = HWC and Original Applicant = EXTREMITY MEDICAL LLC
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