Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 14, 2018
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.
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 up…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Integrity Implants Inc. recalled FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) Instructions… - a moderate-severity action.
FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) Instructions… was recalled by Integrity Implants Inc. in November 14, 2018. Reason: Recently Integrity Implants uncovered a discrepancy in the cleaning parameters in several of their labeling m…. Check the official notice for the remedy. Verify recall #Z-0405-2019 with the FDA Devices before acting.
The recall
Integrity Implants Inc. issued this moderate-severity FDA Devices recall-Recently Integrity Implants uncovered a discrepancy in the cleaning parameters in several of their labeling m….
- Moderate
- severity level
- Class II
- classification
- November 14, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0405-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0405-2019) was formally reported on November 14, 2018, with the manufacturer initiating the action on February 27, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Integrity Implants Inc. is listed as the recalling firm, operating out of Cooper City, FL. Federal records list the affected scope as 75 sets.
The documented reason for this recall is: 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 acc… Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
75 sets
Related Recalls
6
0 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0405-2019 |
| Date reported | November 14, 2018 |
| Date initiated | February 27, 2018 |
| Recalling firm | Integrity Implants Inc. |
| Firm location | Cooper City, FL |
| Affected scope | 75 sets |
| 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0405-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Integrity Implants Inc.. Units affected: 75 sets.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 14, 2018. Severity: Moderate. Recall number: Z-0405-2019.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0405-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 14, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.