FlareHawk Interbody Fusion System — Class II medical device recall Z-0405-2019
Terminated recall by Integrity Implants Inc., reported 2018-11-14, distributed nationwide. Recently Integrity Implants uncovered a discrepancy in the cleaning parameters in several of their labeling ma
| Recall number | Z-0405-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integrity Implants Inc., Cooper City, FL, United States |
| Recall initiated | 2018-02-27 |
| Classified | 2018-11-07 |
| Reported by FDA | 2018-11-14 |
| Terminated | 2019-05-06 |
| Distributed | Nationwide (US) |
| Quantity | 75 sets |
| Reason classes | labeling |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0405-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.