Medtronic Xomed, Inc.: Device Recall

Recall #Z-3130-2024 · 07/05/2024

Class II: Risk

Recall Details

Recall Number: Z-3130-2024
Classification: Class II
Product Type: Device
Recalling Firm: Medtronic Xomed, Inc.
Status: Ongoing
Date Initiated: 07/05/2024
Location: Jacksonville, FL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1 unit

Reason for Recall

Product was distributed past expiration date.

Product Description

Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069

Distribution Pattern

International distribution to the country of Canada.

Other Recalls by Medtronic Xomed, Inc.

Class II: Risk 07/17/2025

Due to out of the box wobble of the driver.
Class II: Risk 03/10/2025

Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical intervention.
Class I: Dangerous 06/24/2024

Potential for false negative response on the NIM Vital Nerve Monitoring System

View all recalls by Medtronic Xomed, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.