Exact FDA event identifier

Event 78479

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

Open FDA event record

Event summary

Timeline bucket: September 28, 2017
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Cosmedent, 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

Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin.

Z-0741-2018

Recall number: Z-0741-2018
Initiated: September 28, 2017
Classification: Class II
Status: Terminated
Recalling firm: Cosmedent, Inc.
Quantity: 84 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material.

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

Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material.

Code information

SKU #663-103, Lot No. 164222A, Exp. Date 10/31/2019

Distribution pattern

Worldwide Distribution -- USA, to the states of IL, LA, MI, PA, and WI; and, to the countries of Australia, Hungary, and Spain.