FDA-Device2014-12-17Class II
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.
Instrumed International, Inc.
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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.
Sold states
Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
Affected count
3 McKenzie enlarging burrs
Manufactured in
626 Cooper Ct, N/A, Schaumburg, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0547-2015Don't want to check this manually?
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