Recall archive / FDA device enforcement
Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069 — FDA record Z-3130-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 5, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069
- Reason
- Product was distributed past expiration date.
- Classification
- Class II
- Recalling firm
- Medtronic Xomed, Inc.
- Quantity
- 1 unit
- Agency-reported status
- Ongoing
- Source record identifier
- Z-3130-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI/DI 0076300004142, Lot Number 0219937928 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution to the country of Canada.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Sep 18, 2024
- Recall initiation date
- Jul 5, 2024
- Center classification date
- Sep 12, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.