Integrity Implants Recalls FlareHawk Interbody Fusion System Instructions for Use
Integrity Implants is correcting Instructions for Use for the FlareHawk Interbody Fusion System due to discrepancies in cleaning parameters.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II recall involving a labeling error regarding cleaning parameters. It is classified as Moderate because it is a documentation issue without reported injuries or illnesses, fitting the criteria for minor labeling errors or voluntary precautionary recalls.
Plain-English summary
Integrity Implants Inc. is initiating a field correction for the Instructions for Use (IFU) associated with the FlareHawk Interbody Fusion System, previously known as the XCage Interbody Fusion System. The recall involves 75 sets of IFUs distributed nationwide in the United States, specifically 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.
The firm identified a discrepancy in the cleaning parameters listed in several labeling materials. This field correction is being implemented to ensure that updated and accurate information is provided to all accounts. The affected documents include the FlareHawk Instructions for Use (IFU-0150, Rev E), the FlareHawk Surgical Technique Manual (STM-00001, Rev A), and the FlareHawk Surgical Technical Manual (STM-0336, Rev C).
This recall applies to the documentation only, not the physical devices. The FlareHawk Interbody Fusion System is indicated for spinal intervertebral body fusion with autogenous bone graft in skeletally mature individuals with degenerative disc disease. Users should refer to the updated instructions provided by the firm for accurate cleaning parameters.
The recalled product
- 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.
- Manufacturer
- Integrity Implants Inc.
- Hazard
- Affected units
- 75
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Rev E FlareHawk Surgical Technique Manual STM-00001
- Rev A FlareHawk Surgical Technical Manual 1-STM-0336
- Rev C
Distribution
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