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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66723

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

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Event summary

Timeline bucket
May 29, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Synthes USA HQ, 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

Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER is used for buttressing multi fragmentary diatal femur fractures including: supra-condylar, intra-articular and extra articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nonunions and malunions.

Z-0401-2014
Recall number
Z-0401-2014
Initiated
May 29, 2013
Classification
Class II
Status
Terminated
Recalling firm
Synthes USA HQ, Inc.
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A plate was inadvertently released to a sales consultant that was restricted for sale.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A plate was inadvertently released to a sales consultant that was restricted for sale.

Code information

part 04.124.406S, lot 3771678.

Distribution pattern

US Distribution in Colorado.