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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80667

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

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Event summary

Timeline bucket
July 13, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Exactech, 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

Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements.

Z-2966-2018
Recall number
Z-2966-2018
Initiated
July 13, 2018
Classification
Class II
Status
Terminated
Recalling firm
Exactech, Inc.
Quantity
7 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Exactech is recalling the Tibial Alignment Guide because the Global Trade Item Number (GTIN) on the device is incorrect. The GTIN on the device reads 10885862525629, when it should read 10885862525628.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Exactech is recalling the Tibial Alignment Guide because the Global Trade Item Number (GTIN) on the device is incorrect. The GTIN on the device reads 10885862525629, when it should read 10885862525628.

Code information

GTIN10885862525629, Lot Number 098299003

Distribution pattern

CA, OH, NY, OK, FL, TX, SC, Germany, Spain, Switzerland, and UK