Instrumed International, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0547-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: September 8, 2014

Date Posted: December 17, 2014

Recall Number: Z-0547-2015

Event ID: 69471

Reason for Recall:

The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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

Status: Terminated

Product Quantity: 3 McKenzie enlarging burrs

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.

Voluntary or Mandated:

Voluntary: Firm initiated