Recall Z-0405-2019 · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Integrity Implants Inc.
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.
| Date | Feb 27, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | The firm is instructing customers to verify their inventory and return the recalled labeling material and replace them with the revised instructions and send the tracking form back to the firm. |
| Quantity | 75 sets |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160076 | XCage Interbody Fusion System Ouroboros Medical, Inc., Oct 13, 2016 |