Class 3 Device Recall Medtronic Xomed

• Date Initiated by Firm: January 29, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on May 03, 2012
• Recall Number: Z-0953-04
• Recall Event ID: 28980
• Product Classification: Bur, Surgical, General & Plastic Surgery - Product Code GFF
• Product: Product is a surgical nasal/sinus surgical device labeled as a RAD Frontal Finesse Bur, Reference Number 18-83070
• Code Information: Lot 26371200
• Recalling Firm/ Manufacturer: Medtronic Xomed, Inc.; 6743 Southpoint Dr N; Jacksonville FL 32216-6218
• For Additional Information Contact: David S. Dodd; 904-279-7532
• Manufacturer Reason for Recall: The curve in the shaft of the bur was only 15 degrees not the labeled 40 degrees.
• FDA Determined Cause: Other
• 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.
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.