Home / Recalls / Extremity Medical LLC / Z-0752-2013

Z-0752-2013 Class II Terminated

Recalled by Extremity Medical LLC — Parsippany, NJ

Recall Details

Product Type: Devices
Report Date: February 6, 2013
Initiation Date: March 22, 2012
Termination Date: June 13, 2013
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 93 units

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 device.

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).

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.

Code Information

Catalog Number 101-00010 Lot number AP3V12 AP4E01 AP4N04 AP5E25 AP6A44 AP6E42 AP6L14 AP6M17 AP6T08