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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86342

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

Open FDA event record

Event summary

Timeline bucket
August 24, 2020
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

EVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and small bone fragments.

Z-2945-2020
Recall number
Z-2945-2020
Initiated
August 24, 2020
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew, Inc.
Quantity
71 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Multiple or incorrect expiration dates were provided on the affected designation labels.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Multiple or incorrect expiration dates were provided on the affected designation labels.

Code information

Part Numbers: 72424030, 72424010, 72424012, 72424016, 72424018, 72424020, 72424022, 72424024, 72434026, 72434028, 72434030, 72423014, 72423016, 72434065, 72434070, 72434075, 72412465, 72424032, 72424040, 72424055, 72424075, 72424080, 72423044. Batch/Lots: 14FM17199R, 14FM01226R, 14FM01227R, 14FM02610R, 14FM03418R, 14FM03420R, 14FM03422R, 14FM03424R, 14FM13578R, 14FM13580R, 14FM13581R, 14FM15166R, 14FM15167R, 14FM16225R, 14FM16228R, 14FM16229R, 14FM16386R, 14FM17201R, 14FM18527R, 14FM19218R, 14FM19226R, 14FM19229R, 14FM19360R.

Distribution pattern

International Distribution to the countries of Denmark, Sweden, France and Spain.