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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69432

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

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Event summary

Timeline bucket
October 02, 2014
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

DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715

Z-0092-2015
Recall number
Z-0092-2015
Initiated
October 02, 2014
Classification
Class II
Status
Terminated
Recalling firm
Synthes, Inc.
Quantity
11

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Particle residue on the instrument from adhesive tape which was used to bind the device during transport. There may be a risk of tissue reaction if a patient is exposed to latex particles from the adhesive tape, or a systemic reaction such as anaphylaxis in patients with latex allergy.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Particle residue on the instrument from adhesive tape which was used to bind the device during transport. There may be a risk of tissue reaction if a patient is exposed to latex particles from the adhesive tape, or a systemic reaction such as anaphylaxis in patients with latex allergy.

Code information

Radiolucent Retractor for Upper Cervical Spine part number 387.580, lot number 3620715.

Distribution pattern

US Distribution including the states of PA, NC, TN, NY, WI, WA and MI.