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.

Reason: The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.

Code information: 1) Instrumed Product Name: McKenzie Enlarging Burr; Instrumed Product Number: 600-00606; Trade Name: CareFusion; CareFusion Product Name: McKenzie Enlarging Burr; CareFusion Item Number: VM85-1255; Lot Number: 030411. 2) Instrumed Product Name: McKenzie Enlarging Burr; Instrumed Product Number: 600-00606; Trade Name: Boss Instruments; Boss Instruments Product Name: McKenzie Enlarging Burr; Boss InstrumentsItem Number: 74-0144; Lot Number: 060311.

Distribution pattern: Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.