Product is a surgical nasal/sinus surgical device labeled as a RAD Frontal Finesse Bur, Reference Number 18-83070
FDA Recall Z-0953-04 · Posted 2004-07-20
Recalling FirmMedtronic Xomed, Inc.
Recall StatusTerminated
Product CodeGFF
Date Initiated2004-01-29
Date Terminated2012-05-03
Product Quantity8 boxes 3 burs per box
Reason for Recall
The curve in the shaft of the bur was only 15 degrees not the labeled 40 degrees.
Firm Action
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
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.