Exact FDA event identifier

Event 68781

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

Open FDA event record

Event summary

Timeline bucket: July 07, 2014
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 Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set.

Z-2067-2014

Recall number: Z-2067-2014
Initiated: July 07, 2014
Classification: Class II
Status: Terminated
Recalling firm: Innovasis, Inc
Quantity: 32

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

mislabeling

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

Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number.

Code information

E2S47525 Lot 1301 and E2S47535 Lot 1301

Distribution pattern

Distribution US nationwide, including TX, CA, KS, MN, and OK. Foreign distribution to Japan.