Exact FDA event identifier

Event 66580

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

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Event summary

Timeline bucket: October 03, 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 Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or fixation, specifically readaptation of torn or avulsed ligaments.

Z-0394-2014

Recall number: Z-0394-2014
Initiated: October 03, 2013
Classification: Class II
Status: Terminated
Recalling firm: Synthes USA HQ, Inc.
Quantity: 3087

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

mislabeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Finished device change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During a retrospective assessment, Spiked Washers 13.5/6.5 were discovered to be mislabeled as Spiked Washers 13.5/5.5.

Code information

part 219.951 with multiple lot#: 2335941 2339634 2397429 2405812 2440475 2442736 2496414 5661855 5663841

Distribution pattern

Nationwide Distribution