CLASS II ONGOING Device recall · Reported 18 Sep 2024 · FDA Enforcement Report
Medtronic ENT Ultra Round Steel Cutting Bur recalled by Medtronic Xomed
Medtronic Xomed is recalling Medtronic ENT Ultra Round Steel Cutting Bur. The recall was initiated on 5 Jul 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3130-2024
- FDA event ID
- 95162
- Recalling firm
- Medtronic Xomed, Jacksonville, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Jul 2024
- FDA classified
- 12 Sep 2024
- Reported
- 18 Sep 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Visit
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 5 Jul 2024 | Recall initiated by company | |
| 12 Sep 2024 | Classified by FDA | +69 days |
| 18 Sep 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product was distributed past expiration date.
Product as listed by the FDA
Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069
Where it was distributed
International distribution to the country of Canada.
Questions about this recall
Why was it recalled?
Product was distributed past expiration date.
Which lots are affected?
UDI/DI 0076300004142, Lot Number 0219937928
Where was it sold?
International distribution to the country of Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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