Z-2067-2014Class II

Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation...

Name: Z-2067-2014 Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation...
Creator: Innovasis, Inc
Published: 2014-07-07
License: https://open.fda.gov/license/

Innovasis, Inc / initiated 2014-07-07 / Terminated / root cause: manufacturing process

FDA source

Innovasis, Inc began a recall of 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... on 2014-07-07. FDA classified it as Class II and gives the reason as "Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2067-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-07
Posted: 2014-07-16
Terminated: 2014-08-11
Recalling firm: Innovasis, Inc
Product: 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.
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Distributors were notified by e-mail on 7/7/14, with attached copies of the written letter and forms to be printed, signed and returned to Innovasis. Distributors have been instructed to return all inventory in stock.
Quantity in commerce: 32
Distribution: Distribution US nationwide, including TX, CA, KS, MN, and OK. Foreign distribution to Japan.
Product codes and lots: E2S47525 Lot 1301 and E2S47535 Lot 1301

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2067-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2067-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-23	2014-07-16

Product code NKB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)