Product is a surgical nasal/sinus surgical device labeled as a RAD Frontal Finesse Bur, Reference Number 18-83070

FDA device recall Z-0953-04 · posted 2004-07-20 · Terminated

Recall details

Recalling firm

Medtronic Xomed, Inc.

Reason for recall

The curve in the shaft of the bur was only 15 degrees not the labeled 40 degrees.

Action taken

A Recall notification letter was mailed to each hospital account on January 29, 2004 for each type of device they received which was under recall explaining the error and asking the accounts to remove recalled product from inventory, fax them the response sheet and to return the products.

Root cause

Other

Status

Terminated

Product code

GFF

Quantity affected

8 boxes 3 burs per box

Distribution

Products were distributed to 23 hospitals and surgical centers in NC, NB, IN, UT, TX, NY, WI, MO, TN, ID, OK, FL, MA, WY, NJ, LA.

Date initiated

2004-01-29

Date posted

2004-07-20

Date terminated

2012-05-03

Location

Jacksonville, FL