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Instrumed International, Inc. recalls McKenzie enlarging burrs are bone cutting and drilling instruments that are used without a power source on a patient's s
Recalled December 17, 2014 · FDA recall Z-0547-2015 · Instrumed International
Hazard
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. · FDA Class II
Units
3 McKenzie enlarging burrs
Sold at
Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
Description
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
Product
McKenzie enlarging burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion and Boss Instruments brand names.
Manufacturer(s)
Instrumed International, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →