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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77986

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

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Event summary

Timeline bucket
July 07, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Amendia, 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

Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-drilling variable screws that are intended to be used with the Ceres-C Stand-Alone Cervical System.

Z-0316-2018
Recall number
Z-0316-2018
Initiated
July 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Amendia, Inc
Quantity
40 screws

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Incorrect direct marking and color identification for the affected lot of Ceres Self-Drilling Variable Screws. Although the laser mark and color identify the screws as 12 mm in length, some screws in the lot measure 14 mm in length.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Mixed-up of materials/components

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incorrect direct marking and color identification for the affected lot of Ceres Self-Drilling Variable Screws. Although the laser mark and color identify the screws as 12 mm in length, some screws in the lot measure 14 mm in length.

Code information

Model # 12-31-4012, Lot #133039

Distribution pattern

Distributed to states of: AL, FL, GA, NY, TX, and VA.