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U.S. Department of Health and Human Services

Class 2 Device Recall Extremity Medical LLC

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  Class 2 Device Recall Extremity Medical LLC see related information
Date Initiated by Firm March 22, 2012
Date Posting Updated January 30, 2013
Recall Status1 Terminated 3 on June 13, 2013
Recall Number Z-0752-2013
Recall Event ID 63805
510(K)Number K101700  K121347  
Product Classification Screw, fixation, bone - Product Code HWC
Product Extremity Medical, IO FiX System Accessory. Catalog Number 101-00010.

This screw measuring device is an accessory to the IO FiX Screw and Washer System that is used to measure the length of the screw by placing the depth gauge over the guidewire and down to the bone. Orthopedic device.
Code Information Catalog Number 101-00010, Lot number

AP3V12, AP4E01, AP4N04, AP5E25, AP6A44, AP6E42, AP6L14, AP6M17, AP6T08
Recalling Firm/
Extremity Medical LLC
300 Interpace Pkwy Ste 410A
Parsippany NJ 07054-1148
For Additional Information Contact Mr. Brian A. Smekal
Manufacturer Reason
for Recall
Lag screw measurement is short (approximately 5 mm) when using current screw measuring device (p/n 101-00010) per the IO FIX Surgical Technique Rev C. which can lead to possible inappropriate implant size selection (e.g. shorter screw size selected).
FDA Determined
Cause 2
Device Design
Action Extremity Medical LLC sent e-mail notification dated March 22, 2012, to all affected customers. The email identified the product the problem and the action to be taken by the customers. The email includes a buleeting which informes the customer that an upgrade to the existing instrumentation is being released. The upgrade will replace the existing gauge. Updated pdf versions of the technique guide are also included. Customers are instructed to return the recalled device after swapping out the recalled device with the replacement unit. Customers will be contacted by Extremity and Sales Reps should contact their principal. For further questions please call (973) 588-8980.
Quantity in Commerce 93 units
Distribution Worldwide Distribution -- Nationwide Distribution including the states of AR, AZ, CA, FL, GA, IL, IN, MD, MT, NC, NE, NH, NJ, NY, OH, PA, TN, TX, WI and WA.
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
510(K)s with Product Code = HWC and Original Applicant = RHYTHMLINK INTERNATIONAL, LLC