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U.S. Department of Health and Human Services

Enforcement Report - Week of February 6, 2013

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Product Detail

Product Description 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 implant.
Recall Number Z-0752-2013
Classification Class II
Code Info Catalog Number 101-00010 Lot number AP3V12 AP4E01 AP4N04 AP5E25 AP6A44 AP6E42 AP6L14 AP6M17 AP6T08.
Product Distributed Qty 93 units
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).

Event Detail

Event Id 63805
Product Type Devices
Status Ongoing
Recalling Firm Extremity Medical LLC
City Parsippany
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-03-22
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern 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.