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

FDA Recall #Z-3130-2024 — Class II — July 5, 2024

Recall #Z-3130-2024 Date: July 5, 2024 Classification: Class II Status: Ongoing

Product Description

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

Reason for Recall

Product was distributed past expiration date.

Recalling Firm

Medtronic Xomed, Inc. — Jacksonville, FL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

1 unit

Distribution

International distribution to the country of Canada.

Code Information

UDI/DI 0076300004142, Lot Number 0219937928

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated