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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84559

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

Open FDA event record

Event summary

Timeline bucket
December 16, 2019
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

LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6, REF 71434411; LEGION AP Cutting Block Size 7, REF 71434412; LEGION AP Cutting Block Size 8, REF 71434413. (Orthopaedic manual surgical instrument).

Z-0878-2020
Recall number
Z-0878-2020
Initiated
December 16, 2019
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
59 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Multiple lots of LEGION AP Femoral Cutting Blocks were manufactured with an oversize green plunger hole and therefore do not meet their design specifications.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Multiple lots of LEGION AP Femoral Cutting Blocks were manufactured with an oversize green plunger hole and therefore do not meet their design specifications.

Code information

LEGION AP Cutting Block Size 4, Product Number 71434409, Lot Numbers: 17LM05399, 17LM07852, 17LM07852A; LEGION AP Cutting Block Size 6, Product Number 71434411, Lot Numbers: 17LM05397, 17LM05398, 17LM07849; LEGION AP Cutting Block Size 7, Product Number 71434412, Lot Numbers: 17LM01746, 17LM05390, 17LM05394, 17LM07851; LEGION AP Cutting Block Size 8, Product Number 71434413, Lot Number: 17LM08442.

Distribution pattern

USA: IA, NC, PA, TN. Int'l: CH, BE, GB, AE, CN, DE, NL, BR, FR.