Z-0547-2015Class II

McKenzie enlarging burrs are bone cutting and drilling instruments that are used without a power source on a...

Name: Z-0547-2015 McKenzie enlarging burrs are bone cutting and drilling instruments that are used without a power source on a...
Creator: Instrumed International, Inc.
Published: 2014-09-08
License: https://open.fda.gov/license/

Instrumed International Inc dba Avalign German Specialty Instruments / initiated 2014-09-08 / Terminated

FDA source

Instrumed International, Inc. began a recall of 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... on 2014-09-08. FDA classified it as Class II and gives the reason as "The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0547-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-08
Posted: 2014-12-16
Terminated: 2017-11-29
Recalling firm: Instrumed International Inc dba Avalign German Specialty Instruments
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.
Product code: HBG Drills, Burrs, Trephines & Accessories (Manual)
Reason for recall: The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.
FDA root cause: No Marketing Application
Action: Instrumed sent an URGENT: MEDICAL DEVICE MARKET WITHDRAWAL letters dated October 9, 2014 to all affected customers. The letter included instructions for customers to: 1) examine their inventory to determine if there are any recalled devices; 2) complete and return the enclosed Confirmation Request Form; 3) return the recalled devices; and 4) share the recall information with facility staff. Customers with questions were instructed to contact Instrumed by telephone at 847-908-6119.
Quantity in commerce: 3 McKenzie enlarging burrs
Distribution: Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0547-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0532-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08
Z-0533-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08
Z-0534-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08
Z-0535-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08
Z-0536-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08
Z-0537-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08
Z-0538-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08
Z-0539-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08
Z-0540-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08
Z-0541-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08
Z-0542-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08
Z-0543-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08
Z-0544-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08
Z-0545-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08
Z-0546-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08
Z-0547-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08
Z-0548-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08
Z-0549-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08
Z-0550-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08
Z-0551-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08
Z-0552-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08
Z-0553-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08
Z-0554-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08
Z-0555-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08
Z-0556-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08
Z-0557-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08
Z-0558-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08
Z-0559-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08

Product code HBG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)