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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72878

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

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Event summary

Timeline bucket
December 07, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Innovasis, 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

Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat. No.: SR 55110 5.5 x 110 mm LOT 1502 Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set. Intended for use in the non-cervical area of the spine.

Z-0662-2016
Recall number
Z-0662-2016
Initiated
December 07, 2015
Classification
Class II
Status
Terminated
Recalling firm
Innovasis, Inc
Quantity
17 units Labeled SR55100 Lot 1502 with SR55110 rods in package

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels.

Code information

Catalog No.: SR55110 Lot 1502 and SR55100 Lot 1502

Distribution pattern

Distributed in US -- CA; KS; OH; & TX.