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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 Recall
Extremity Medical LLC
see related information
Date Posted January 30, 2013
Recall Status1 Terminated on June 13, 2013
Recall Number Z-0752-2013
Recall Event ID 63805
Premarket Notification
510(K) Numbers
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/
Manufacturer
Extremity Medical LLC
300 Interpace Pkwy Ste 410A
Parsippany, New Jersey 07054-1148
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Mr. Brian A. Smekal
973-588-8988
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
DESIGN: Component Design/Selection
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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
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