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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78672

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

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Event summary

Timeline bucket
November 29, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Smith & Nephew, 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

smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72442360N, NON-STERILE, Rx only, (01)00885556456446(10), (11)171116 Bone plates and bone screws from the EVOS Mini-Fragment Plating System are intended for use in internal fixation of small bones and small bone fragments and non-load bearing stabilization and reduction of bone fragments in long bones.

Z-0408-2018
Recall number
Z-0408-2018
Initiated
November 29, 2017
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew, Inc.
Quantity
12

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
One lot of EVOS 2.4MM Flex Plate 6 Hole packaging contained templates.

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

One lot of EVOS 2.4MM Flex Plate 6 Hole packaging contained templates.

Code information

17AM14602

Distribution pattern

US Distribution to the state of OR, and Internationally to Colombia.