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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77171

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

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Event summary

Timeline bucket
May 02, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Implant Direct Sybron Manufacturing, LLC

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

Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD

Z-2125-2017
Recall number
Z-2125-2017
Initiated
May 02, 2017
Classification
Class II
Status
Terminated
Quantity
151 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Implant Direct Sybron Manufacturing is recalling the Legacy Full-Contour Abutment 3.5mmD Assembly because it may be out of Implant Direct specification.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Implant Direct Sybron Manufacturing is recalling the Legacy Full-Contour Abutment 3.5mmD Assembly because it may be out of Implant Direct specification.

Code information

89103, 83493, 78986

Distribution pattern

Worldwide Distribution - Nationwide Distribution and to the countries of : European Union (HU, GB, DE, DK, IT, HR, FR), and Japan