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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Integrity Implants Inc.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0405-2019
Related Recalls
Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C).
Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank.
Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank.