Z-3130-2024Class II

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

Name: Z-3130-2024 Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069
Creator: Medtronic Xomed, Inc.
Published: 2024-07-05
License: https://open.fda.gov/license/

Medtronic Xomed, Inc. / initiated 2024-07-05 / Open, Classified

FDA source

Medtronic Xomed, Inc. began a recall of Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069 on 2024-07-05. FDA classified it as Class II and gives the reason as "Product was distributed past expiration date". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-3130-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-07-05
Posted: 2024-09-12
Recalling firm: Medtronic Xomed, Inc.
Product: Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069
Product code: EQJ Bur, Ear, Nose And Throat
Reason for recall: Product was distributed past expiration date.
FDA root 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.
Product codes and lots: UDI/DI 0076300004142, Lot Number 0219937928

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3130-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3130-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-12

Product code EQJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)