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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66529

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

Open FDA event record

Event summary

Timeline bucket
September 24, 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-0341-2014
Recall number
Z-0341-2014
Initiated
September 24, 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 potential exists for the locking screw nut to break on the Soft Tissue Retractor if it is overt-tightened.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential exists for the locking screw nut to break on the Soft Tissue Retractor if it is overt-tightened.

Code information

Part # Lot # 325.01 1776332 325.01 1834589 325.01 1855361 325.01 1893067 325.01 1903596 325.01 1952258 325.01 1986932 325.01 3067805 325.01 3150691 325.01 3179456 325.01 3186865 325.01 3220973 325.01 3241083 325.01 3268079 325.01 3360992 325.01 3719234 325.01 3818913 325.01 4948929 325.01 4994679 325.01 4994680 325.01 5031083 325.01 5031085 325.01 5391773 325.01 5420979 325.01 5420980 325.01 5476369 325.01 5476370 325.01 5510070 325.01 5544585 325.01 5546329 325.01 5563699 325.01 5569041 325.01 5624246 325.01 5657366 325.01 5677289 325.01 5759764 325.01 5759765 325.01 5779363 325.01 7698954 325.01 7826103

Distribution pattern

Worldwide Distribution - USA (Nationwide) and Canada.