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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70579

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

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Event summary

Timeline bucket
February 24, 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

Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused.

Z-1352-2015
Recall number
Z-1352-2015
Initiated
February 24, 2015
Classification
Class II
Status
Terminated
Recalling firm
Synthes, Inc.
Quantity
131

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and removal of instruments.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and removal of instruments.

Code information

Part Numbers: 03.037.013, 03.037.014, Lot Numbers: 8903848, 9124017, 903851, 9124019, 8918566, 9124022, 9124012, 9124023, 9124014, 9124026, 9124016, 9124027, 8918563

Distribution pattern

US Nationwide Distribution - NY, TX, MD, OR, MS, ND, CA, AZ, MI, IL, PA, TN, AR, SD, SC, FL, VA, OK, and GA