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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78946

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

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Event summary

Timeline bucket
January 08, 2018
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 Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic deformities of the thoracic, lumbar, and sacral spine:

Z-0644-2018
Recall number
Z-0644-2018
Initiated
January 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Innovasis, Inc
Quantity
1,010 parts

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage.

Code information

Catalog/Part No.: E2S8530, E2S8535, E2S8540, E2S8545, E2S8550, E2S8555, E2S8560 with Lot Number: 1101 and Catalog/Part No.: E28540, E28545 with Lot Number: 1201. Each of these parts is engraved with part number and lot number.

Distribution pattern

United States