Z-0644-2018Class II

Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended...

Name: Z-0644-2018 Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended...
Creator: Innovasis, Inc
Published: 2018-01-08
License: https://open.fda.gov/license/

Innovasis, Inc / initiated 2018-01-08 / Terminated / root cause: manufacturing process

FDA source

Innovasis, Inc began a recall of Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of... on 2018-01-08. FDA classified it as Class II and gives the reason as "Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage". 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-0644-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-08
Posted: 2018-02-20
Terminated: 2018-02-27
Recalling firm: Innovasis, Inc
Product: 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:
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The distributors were notified of the recall on 1/8/2018 via email with an attached pdf. They are also being asked to confirm or deny the quantities showing in inventory via a Product Removal Form sent in the same email.
Quantity in commerce: 1,010 parts
Distribution: United States
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0644-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0644-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-20

Product code NKB

K102248Class IIExcella II Spinal System Model Ec2-00Innovasis, Inc. / cleared 2010-10-07

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)