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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71440

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

Open FDA event record

Event summary

Timeline bucket
June 03, 2015
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

TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre-and post-isthmic fractures; and tibial malunions and non-unions.

Z-2051-2015
Recall number
Z-2051-2015
Initiated
June 03, 2015
Classification
Class II
Status
Terminated
Recalling firm
Synthes, Inc.
Quantity
3

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A specific part and lot number was packaged and shipped prior to the completion of a required internal inspection.

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 specific part and lot number was packaged and shipped prior to the completion of a required internal inspection.

Code information

Part # 04.004.000, lot # 7950994

Distribution pattern

US Distribution to states of: MO and SC.