Alphatec Calibrate CCX Interbody Systems Recalled for Implant Collapse

What You Should Do

1. This recall affects Alphatec Calibrate CCX-O and CCX-S Interbody System implants and convenience kits, including various model dimensions and angles used for spinal fusion.
2. Hospitals and surgical centers should check their inventory for 25 different implant models and specific kit serial numbers. See the Affected Products section below for the full list of affected codes.
3. Stop using any recalled implants or convenience kits immediately and quarantine them to prevent surgical use.
4. Contact Alphatec Spine, Inc. or your distributor to arrange for the return, replacement, or correction of the affected devices.
5. If you are a patient who has received one of these implants and are experiencing new or worsening pain, contact your surgeon or healthcare provider.
6. For additional information or questions, call the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

Affected Products