Recall Z-0405-2019— Integrity Implants Inc.
Class II · Terminated
Class II FDA medical device recall by Integrity Implants Inc., initiated 2018-02-27, terminated 2019-05-06. It names one FDA 510(k) clearance: K160076. 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.. Reason: 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..
- Recalling firm
- Integrity Implants Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-02-27
- Terminated
- 2019-05-06
- Firm location
- Cooper City, FL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.