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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66552

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 Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade is used to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations thereof. The long TFN is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions.

Z-0369-2014
Recall number
Z-0369-2014
Initiated
October 03, 2013
Classification
Class II
Status
Terminated
Recalling firm
Synthes USA HQ, Inc.
Quantity
350195

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A potential exists for non conforming Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blades to be distributed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

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Inspect official wording and provenance

Reason for recall

A potential exists for non conforming Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blades to be distributed.

Code information

part nos. 456.300-456.310 & 456.650, 456.300S-456.310S & 456.650S, with lot nos. 5615864 through 7423581

Distribution pattern

Worldwide Distribution - USA (nationwide) and Internationally to Mexico and Canada.