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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67390

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

Open FDA event record

Event summary

Timeline bucket
January 27, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Synthes, 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 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral.

Z-0986-2014
Recall number
Z-0986-2014
Initiated
January 27, 2014
Classification
Class II
Status
Terminated
Recalling firm
Synthes, Inc.
Quantity
1,132,096

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Synthes 3.2 mm Guide Wire 400mm included an incorrect raw material listed on the label.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Synthes 3.2 mm Guide Wire 400mm included an incorrect raw material listed on the label.

Code information

part No. 357.399 with all lot numbers 4440270 through 49991803, 5000218 through 5894644, 6000409 through 6999404, 7000143 through 7531836, UK09636, UK10233, UK10510, UL11099, and UL11333.

Distribution pattern

Worldwide Distribution-USA (nationwide) and the countries of Canada and Switzerland.