Innovasis, Inc: Medical Device Recall in 2018 - (Recall #: Z-0644-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: January 8, 2018

Date Posted: February 28, 2018

Recall Number: Z-0644-2018

Event ID: 78946

Reason for Recall:

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

Status: Terminated

Product Quantity: 1,010 parts

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

Voluntary or Mandated:

Voluntary: Firm initiated