# FDA recall Z-0405-2019

> **Integrity Implants Inc.** · Class II · device recall initiated 2018-02-27.

## Product

FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) Instructions for Use (IFU's) only. Product Usage: Indicated for spinal intervertebral body fusion with autogenous bone graft in skeletally mature individuals with degenerative disc disease.

## Reason for recall

Recently Integrity Implants uncovered a discrepancy in the cleaning parameters in several of their labeling material. The firm is initiating the field correction to ensure that updated information is provided to all accounts.

## Distribution

US nationwide in the states of AZ, CA, CO, DC, FL, GA, IA, IL, IN, KS, LA, MA, MS, NJ, NV, NY, OH, OR, PA, RI, SC, TX, and VA.

## Key facts

- **Recall number:** Z-0405-2019
- **Recalling firm:** Integrity Implants Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-02-27
- **Report date:** 2018-11-14
- **Termination date:** 2019-05-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cooper City, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0405-2019

## Citation

> AI Analytics. FDA recall Z-0405-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0405-2019. Source: US FDA. Licensed CC0.

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