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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66419

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

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Event summary

Timeline bucket
July 30, 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 Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fractures

Z-0407-2014
Recall number
Z-0407-2014
Initiated
July 30, 2013
Classification
Class II
Status
Terminated
Recalling firm
Synthes USA HQ, Inc.
Quantity
14

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The packaging incorrectly depicts the Synthes Titanium Cannulated Humeral Nail as a 3 distal hole nail instead of a 2 distal locking hole nail.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The packaging incorrectly depicts the Synthes Titanium Cannulated Humeral Nail as a 3 distal hole nail instead of a 2 distal locking hole nail.

Code information

Part # Lot # 04.001.620S 7115414 04.001.620S 7115417 04.001.620S 7115509 04.001.620S 7115510 04.001.622S 7115533 04.001.636S 7117902 04.001.636S 7117916 04.001.638S 7117924 04.001.640S 7119089 04.001.640S 7119107 04.001.642S 7117995 04.001.642S 7119125 04.001.644S 7117998 04.001.218S 7327816 04.001.444S 7379241 04.001.620s 7265517

Distribution pattern

Worldwide Distribution - USA (nationwide) including SC, IA, NC, TX, KY, VA, AL, PA, and Internationally to Canada.