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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79040

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

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Event summary

Timeline bucket
June 20, 2017
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

Multi-Unit Abutment Angled, 17¿, 4mm Cuff 4.1/4.5mm TiLobe¿ Implants, Catalog Number 45324K pRODUCT Usage: Use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations and terminal or intermediate abutment support for fixed bridgework.

Z-0608-2018
Recall number
Z-0608-2018
Initiated
June 20, 2017
Classification
Class II
Status
Terminated
Recalling firm
Keystone Dental Inc
Quantity
20 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Abutments are unable to accept the final abutment screw

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

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Inspect official wording and provenance

Reason for recall

Abutments are unable to accept the final abutment screw

Code information

REF - 45324K Lot Number - 33006 Expiry Date - March 31, 2022

Distribution pattern

US Nationwide Distribution in the states of ND, NJ & MA