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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81100

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

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Event summary

Timeline bucket
September 18, 2018
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 Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral Cutting Block is a reusable surgical instrument used to make bone cuts on the distal femur to prepare the bone to receive a LEGION femoral implant.

Z-0200-2019
Recall number
Z-0200-2019
Initiated
September 18, 2018
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew, Inc.
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
One lot of the Legion AP femoral cutting block, size 6, was manufactured with an oversized spring.

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

One lot of the Legion AP femoral cutting block, size 6, was manufactured with an oversized spring.

Code information

Lot 17LM05396

Distribution pattern

US Distribution to the states of: KS and TN.