Exact FDA event identifier

Event 79994

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

Open FDA event record

Event summary

Timeline bucket: April 13, 2018
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Coltene Whaledent 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

Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made from carbon steel or tungsten carbide intended to cut hard structures in the mouth, such as teeth or bone.

Z-1883-2018

Recall number: Z-1883-2018
Initiated: April 13, 2018
Classification: Class II
Status: Terminated
Recalling firm: Coltene Whaledent Inc
Quantity: 11

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The products are labeled with an incorrect product number.

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

The products are labeled with an incorrect product number.

Code information

Batch I37640

Distribution pattern

The products were distributed to the following US states: NY. The products were distributed to the following foreign countries: Canada