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

FDA device recall Z-0547-2015 · posted 2014-12-16 · Terminated

Recall details

Recalling firm

Instrumed International, Inc.

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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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

Action taken

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.

Root cause

No Marketing Application

Status

Terminated

Product code

HBG

Quantity affected

3 McKenzie enlarging burrs

Distribution

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

Date initiated

2014-09-08

Date posted

2014-12-16

Date terminated

2017-11-29

Location

Schaumburg, IL