Class 2 Device Recall ENT Ultra Round Steel Cutting Bur

• Date Initiated by Firm: July 05, 2024
• Date Posted: September 12, 2024
• Recall Status: Open, Classified
• Recall Number: Z-3130-2024
• Recall Event ID: 95162
• Product Classification: Bur, ear, nose and throat - Product Code EQJ
• Product: Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069
• Code Information: UDI/DI 0076300004142, Lot Number 0219937928
• FEI Number: 1045254
• Recalling Firm/ Manufacturer: Medtronic Xomed, Inc.; 6743 Southpoint Dr N; Jacksonville FL 32216-6218
• For Additional Information Contact: Marie Gentile; 904-693-6028
• Manufacturer Reason for Recall: Product was distributed past expiration date.
• FDA Determined Cause: Under Investigation by firm
• Action: Medtronic issued an URGENT: MEDICAL DEVICE RECALL notice to its sole consignee on 07/05/2024 via in person visit. The notice explained the problem, potential risk if used, and requested the product be quarantined.
• Quantity in Commerce: 1 unit
• Distribution: International distribution to the country of Canada.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.