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Recall Observatory FDA recall evidence

Device product

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

Z-3130-2024

July 05, 2024

Class II

Product summary

Firm
Medtronic Xomed, Inc.
Event
Event 95162
Status
Ongoing
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-3130-2024

Official wording

Reason: Product was distributed past expiration date.

Code information: UDI/DI 0076300004142, Lot Number 0219937928

Distribution pattern: International distribution to the country of Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product was distributed past expiration date.