Manual bunnell cranial drills are bone cutting and drilling instruments that are used without a power source on a patient's skull sold under the Boss Instruments brand name.

Reason: The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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: Bunnell Drill, 5 3/4", w/ chuck key; Instrumed Product Number: 590-05389; Trade Name: Boss Instruments; Boss Instruments Product Name: Bunnell Drill, 5 3/4"; Boss Instruments Item Number: 74-1240; Lot Numbers: 030511, 060110, 070311.

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