# FDA recall Z-0644-2018

> **Innovasis, Inc** · Class II · device recall initiated 2018-01-08.

## 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:

## Reason for recall

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

## Distribution

United States

## Key facts

- **Recall number:** Z-0644-2018
- **Recalling firm:** Innovasis, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-08
- **Report date:** 2018-02-28
- **Termination date:** 2018-02-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Salt Lake City, UT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0644-2018

## Citation

> AI Analytics. FDA recall Z-0644-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0644-2018. Source: US FDA. Licensed CC0.

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