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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79615

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

Open FDA event record

Event summary

Timeline bucket
January 24, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Keystone Dental 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

Stage-1 Tissue Punch, Disposable, 4.5mm; catalog number: ISS141K. Intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations.

Z-1443-2018
Recall number
Z-1443-2018
Initiated
January 24, 2018
Classification
Class II
Status
Terminated
Recalling firm
Keystone Dental Inc
Quantity
101

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The cutting edge of tissue punches may be potentially damaged with small dents and nicks.

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 cutting edge of tissue punches may be potentially damaged with small dents and nicks.

Code information

Lot numbers: 33434, expiration date: 2022-04; 33945, expiration date: 2022-05; 34294, expiration date: 2022-06; and 34987, expiration date: 2022-07.

Distribution pattern

Worldwide Distribution -- US, to the state of California; and, the countries of Canada and Germany