Home / Recalls / Medical Devices
Extremity Medical LLC recalls Extremity Medical, IO FiX System Accessory. Catalog Number 101-00010. This screw measuring device is an accessory
Recalled February 6, 2013 · FDA recall Z-0752-2013 · Extremity Medical
Hazard
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 Class II
Units
93 units
Sold at
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.
Description
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).
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.
Manufacturer(s)
Extremity Medical LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →