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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69759

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 04, 2014
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

3 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 3

LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 4, LEFT, REF 71425004, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.

Z-0589-2015
Recall number
Z-0589-2015
Initiated
November 04, 2014
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew, Inc.
Quantity
24 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The stem taper on this device is undersized; the gauge point is not deep enough.

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

The stem taper on this device is undersized; the gauge point is not deep enough.

Code information

Lot Number 14FM05730

Distribution pattern

Worldwide Distribution: US (nationwide) including states of: MI, MN, MO, OH, PA, IA, and TN; and Internationally to: SWITZERLAND; CANADA, COLOMBIA, GERMANY, Dubai, (UAE), THAILAND; SOUTH AFRICA, SOUTH KOREA; and SINGAPORE.

device · product 2 of 3

LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 5, RIGHT, REF 71426005, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.

Z-0590-2015
Recall number
Z-0590-2015
Initiated
November 04, 2014
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew, Inc.
Quantity
45 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The stem taper on this device is undersized; the gauge point is not deep enough.

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

The stem taper on this device is undersized; the gauge point is not deep enough.

Code information

Lot Numbers: 14EM16708, 14EM21988, 14DM22269

Distribution pattern

Worldwide Distribution: US (nationwide) including states of: MI, MN, MO, OH, PA, IA, and TN; and Internationally to: SWITZERLAND; CANADA, COLOMBIA, GERMANY, Dubai, (UAE), THAILAND; SOUTH AFRICA, SOUTH KOREA; and SINGAPORE.

device · product 3 of 3

LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 6, LEFT, REF 71426006, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.

Z-0591-2015
Recall number
Z-0591-2015
Initiated
November 04, 2014
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew, Inc.
Quantity
23 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The stem taper on this device is undersized; the gauge point is not deep enough.

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

The stem taper on this device is undersized; the gauge point is not deep enough.

Code information

Lot Number 14EM23391

Distribution pattern

Worldwide Distribution: US (nationwide) including states of: MI, MN, MO, OH, PA, IA, and TN; and Internationally to: SWITZERLAND; CANADA, COLOMBIA, GERMANY, Dubai, (UAE), THAILAND; SOUTH AFRICA, SOUTH KOREA; and SINGAPORE.