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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94555

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

Open FDA event record

Event summary

Timeline bucket
April 24, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
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 OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71343604, 36 MM M / +4

Z-1901-2024
Recall number
Z-1901-2024
Initiated
April 24, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew Inc
Quantity
23 packages

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Packaging contained the incorrect size of femoral head from what was displayed on the label.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Packaging contained the incorrect size of femoral head from what was displayed on the label.

Code information

REF 71343204 - Batch #23FM03219, Exp. June 2033; REF 71343604 - Batch 23FM04184, Exp. June 2033.

Distribution pattern

International distribution to the countries of Australia, Germany, Japan, Portugal, and United Kingdom.