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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71509

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

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Event summary

Timeline bucket
June 05, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Cochlear Americas 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

Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Sterile Silicone Template is used in the sterile field to check the size of the periosteal pocket, the shape and depth of the implant well and appropriate positions for tie down holes

Z-2155-2015
Recall number
Z-2155-2015
Initiated
June 05, 2015
Classification
Class II
Status
Terminated
Recalling firm
Cochlear Americas Inc.
Quantity
26

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed.

Code information

Lot numbers: COH471122 Expiration 5/6/15 and Lot COH471123 Expiration 4/24/15

Distribution pattern

US Nationwide Distribution to CO, OH, OR, MI, and CA.