Z-0405-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 14, 2018
- Initiation Date
- February 27, 2018
- Termination Date
- May 6, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 75 sets
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.
Distribution Pattern
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.
Code Information
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