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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79548

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 03, 2017
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Gyrus ACMI, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system

Z-1337-2018
Recall number
Z-1337-2018
Initiated
August 03, 2017
Classification
Class II
Status
Ongoing
Recalling firm
Gyrus ACMI, Inc.
Quantity
324

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
"Chattering" when cutting burrs are used in bone.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

"Chattering" when cutting burrs are used in bone.

Code information

Catalog No. (UDI-DI): MBUR5060FRCV (00821925036529), MBUR6060FRCV (00821925036536), and MBUR7060FRCV (00821925036543) ALL LOTS MANUFACTURED BEFORE AUGUST 3, 2017

Distribution pattern

NM, MI, and TX EU, Australia, Japan, and Hong Kong

Field note

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