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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89461

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

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Event summary

Timeline bucket
February 09, 2022
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Wright Medical Technology, 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

The DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plates use either 2.7mm or 3.5mm screws which intersect each other in pairs. The drill holes of the plates are aligned to assure the screws do not touch. The various plates model numbers differ from each other through among other things different curvatures, material strengths, lengths, number of plate holes and through different grades and bridge widths

Z-0679-2022
Recall number
Z-0679-2022
Initiated
February 09, 2022
Classification
Class II
Status
Terminated
Quantity
12 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product was labelled with the incorrect manufacturing and distribution dates.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product was labelled with the incorrect manufacturing and distribution dates.

Code information

Model No. DCS2825126; Lot No. 11012187061566009

Distribution pattern

International distribution in the countries of Japan and the United Kingdom.