Recall Z-1065-2025 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Alphatec Spine, Inc.
Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-O, 7 x 10 x 25mm 5 degrees, Part #325-07102505, nonsterile; (2) Calibrate CCX-O, 7 x 10 x 25mm 10 degrees, Part #325-07102510, nonsterile; (3) Calibrate CCX-O, 7 x 10 x 25mm 15 degrees, Part #325-07102515, nonsterile; (4) Calibrate CCX-O, 7 X 10 X 30mm 5 degrees, Part #325-07103005, nonsterile; (5) Cali
| Date | Jan 30, 2025 (initiated Dec 15, 2024) |
| Status | Open, Classified |
| Reason | Complaints have been received regarding post-operative implant collapse. |
| Root cause | Under Investigation by firm |
| Action | The recalling firm issued letters dated 12/13/2024 via email on 12/15/2024. The letter provided an attachment listing the specific device part numbers and lot numbers, the reason for recall, the potential risks, a listing of mitigating factors that should be considered when determining patient care, and field action (recall) instructions for the consignee, which included (1) Review of inventory to determine if any of the affected devices are in the consignee's possession. If the device is in the consignee's possession, the consignee is to abstain from use and contact the recalling firm immed |
| Quantity | 1,127 loose implants; 10/24-implant kits; and 4/36-implant kits (1,511 total implants) |
| Distribution | US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IA, IL, IN, MA, MD, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SC, SD, TN, and UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K232504 | Calibrate CCX Interbody System Alphatec Spine, Inc., Oct 13, 2023 |