Lower risk Medical device recall · FDA · Published February 27, 2018

Integrity Implants FlareHawk Interbody Fusion System IFU's: Cleaning Parameter Discrepancy

Integrity Implants recalls FlareHawk Interbody Fusion System Instructions for Use (IFU's) due to potential cleaning parameter discrepancies in labeling. Affected users should verify their IFU version and contact the company for updates.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0405-2019Medical device Integrity Implants ›

Lower-risk 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.

Take action

Contact the company

Recalling firmIntegrity Implants Inc.8963 Stirling Rd Ste 8 · Cooper City, FL 33328-5113

✎ GovInfoNow plain-language explainer

Integrity Implants is recalling the FlareHawk Interbody Fusion System Instructions for Use (IFU's) because they found a discrepancy in cleaning parameters in some labeling materials. This recall does not involve the actual medical devices but only the instructions for use, which are critical for safe surgical procedures. Read more at govinfonow.com/recall/71863-integrity-implants-flarehawk-interbody-fusion-system-ifu-s-cleaning-parameter.

Source Summary by GovInfoNow · govinfonow.com/recall/71863-integrity-implants-flarehawk-interbody-fusion-system-ifu-s-cleaning-parameter · Updated August 27, 2026 · FDA enforcement record: FDA #Z-0405-2019

Cite this page

“Integrity Implants FlareHawk Interbody Fusion System IFU's: Cleaning Parameter Discrepancy.” GovInfoNow, updated August 27, 2026. https://govinfonow.com/recall/71863-integrity-implants-flarehawk-interbody-fusion-system-ifu-s-cleaning-parameter. Based on FDA recall #Z-0405-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0405-2019%22&limit=1).

Integrity Implants Inc. recalled FlareHawk Interbody Fusion System Instructions for Use (IFUs) only due to a discrepancy in cleaning parameters in labeling materials, according to the FDA. The Food and Drug Administration announced the Class II voluntary recall on Feb. 27, 2018.

How to tell if you have it

Brand: Integrity Implants
Product: FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) Instructions for Use (IFUs)
Specific IFUs: IFU-0150, Rev E; STM-00001, Rev A; STM-0336, Rev C
Quantity: 75 sets
Distribution: US nationwide in AZ, CA, CO, DC, FL, GA, IA, IL, IN, KS, LA, MA, MS, NJ, NV, NY, OH, OR, PA, RI, SC, TX, and VA

The hazard

The firm uncovered a discrepancy in the cleaning parameters in several of their labeling materials. The field correction ensures that updated information is provided to all accounts.

Context

GovInfoNow's records show Integrity Implants Inc. has three other recalls on record since Jan. 27, 2022. Other recent recalls of similar products include FIREBIRD SI Fusion System labeling inconsistencies (Nov. 3, 2025) and Encore Medical EMPOWR Acetabular System packaging discrepancy (Jan. 5, 2026).

How to tell if you have this one

Check for FlareHawk Interbody Fusion System Instructions for Use (IFU's) with the following versions: IFU-0150 Rev E, STM-00001 Rev A, or STM-0336 Rev C. These are the specific labeling materials affected by the cleaning parameter discrepancy.

Brand
Integrity Implants
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Verify Your IFU Version
Check the version number on your FlareHawk Interbody Fusion System Instructions for Use (IFU) to confirm if it matches the affected versions listed.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 22 states.

FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, California, Colorado, District of Columbia, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Louisiana, Massachusetts, Mississippi, Nevada, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia.

Recall timeline

FDA terminated this recall 14 months after the firm started it.

Feb 27, 2018Firm started the recall
Nov 7, 2018FDA classified it Class II
Nov 14, 2018Published in FDA’s Enforcement Report
May 6, 2019FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/71863-integrity-implants-flarehawk-interbody-fusion-system-ifu-s-cleaning-parameter">Integrity Implants FlareHawk Interbody Fusion System IFU's: Cleaning Parameter Discrepancy (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0405-2019 (February 27, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0405-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 27, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.