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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83596

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

Open FDA event record

Event summary

Timeline bucket
January 15, 2018
Product types
Device
Classifications
Class II
Statuses
Completed
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(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71423432 Product Usage: The constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or lateral collateral ligament) are absent or incompetent.

Z-2538-2019
Recall number
Z-2538-2019
Initiated
January 15, 2018
Classification
Class II
Status
Completed
Recalling firm
Smith & Nephew, Inc.
Quantity
12 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The affected products were inadvertently packaged with an incorrect screw component.

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 affected products were inadvertently packaged with an incorrect screw component.

Code information

13KSL0038C

Distribution pattern

Foreign countries of; France, Germany, Netherlands, Norway, Switzerland