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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67727

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

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Event summary

Timeline bucket
April 25, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Instratek, Incorporated

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

Mini Cannulated Titanium Headed and Headless Screw Set and 2.5, 3.0, and 4.0 mm countersink/depth gauges in the Mini Screw Set/System

Z-2679-2014
Recall number
Z-2679-2014
Initiated
April 25, 2013
Classification
Class II
Status
Terminated
Recalling firm
Instratek, Incorporated
Quantity
96

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Faded and wrong markings on bone screw Countersink/Depth Gauge instruments in Mini Screw Set.

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

Faded and wrong markings on bone screw Countersink/Depth Gauge instruments in Mini Screw Set.

Code information

Mini System part no. IS1100 - lot 0001-0047; Instrument part nos. IS1103, IS1104, and IS1105 - lots 918101, 918102, and 918103

Distribution pattern

Nationwide: Maine, Oregon, Florida, Texas, Virginia, Arizona, Nebraska, California, Ohio, Illinois, Oklahoma, Washington, North Carolina, Arkansas, Tennessee, New Mexico, Connecticut, Colorado