Reported Nov 14, 2018 · Terminated
FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) Instructions for Use (IFU's) only. Product…
Integrity Implants Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Integrity Implants Inc. · 8963 Stirling Rd Ste 8 · Cooper City, FL · 33328-5113
Is this the product you have?
- FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) Instructions for Use (IFU's) only
- Product UsageIndicated for spinal intervertebral body fusion with autogenous bone graft in skeletally mature individuals with degenerative disc disease
- Lot codes and dates
- ALL Lots of devices are affected - IFU's are added at the time of fulfillment. FlareHawk Instructions for Use 1- IFU-0150, Rev E FlareHawk Surgical Technique Manual STM-00001, Rev A FlareHawk Surgical Technical Manual 1-STM-0336, Rev C
- Amount recalled
- 75 sets
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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