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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66530

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

Open FDA event record

Event summary

Timeline bucket
August 01, 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 Soft Tissue Retractor Small Extendible. Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.

Z-0429-2014
Recall number
Z-0429-2014
Initiated
August 01, 2013
Classification
Class II
Status
Terminated
Recalling firm
Synthes USA HQ, Inc.
Quantity
374

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The small extendible Soft Tissue Retractor was recalled due to locking nut (clamping sleeve) malfunction.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

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Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The small extendible Soft Tissue Retractor was recalled due to locking nut (clamping sleeve) malfunction.

Code information

Part J5957AC (old), and Part J5957F (new)

Distribution pattern

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