Alphatec Calibrate CCX Interbody System Recall: Post-Op Implant Collapse Risk
Alphatec recalls Calibrate CCX interbody implants for spinal fusion due to reported post-operative collapse. Affected models include specific sizes and lot numbers. Check your implant details to determine if recalled.
Lower-risk recall
Complaints have been received regarding post-operative implant collapse.
Contact the company
What happened, in plain English
Alphatec is recalling certain Calibrate CCX interbody implants used in spinal fusion procedures because complaints indicate these implants can collapse after surgery. This could lead to complications requiring additional surgery or longer recovery. Read more at govinfonow.com/recall/53295-alphatec-calibrate-ccx-interbody-system-recall-post-op-implant-collapse.
Source Summary by GovInfoNow · govinfonow.com/recall/53295-alphatec-calibrate-ccx-interbody-system-recall-post-op-implant-collapse · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1065-2025
Cite this page
“Alphatec Calibrate CCX Interbody System Recall: Post-Op Implant Collapse Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53295-alphatec-calibrate-ccx-interbody-system-recall-post-op-implant-collapse. Based on FDA recall #Z-1065-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1065-2025%22&limit=1).
Why it’s dangerous
The implants have been reported to collapse after surgery, which could cause complications such as additional surgery or extended recovery time. This is a mechanical issue with the implant design rather than a safety hazard during normal use.
Who’s affected
Patients who have received the recalled Calibrate CCX-O or Calibrate CCX-S implants for spinal fusion procedures are affected. Surgeons and medical facilities using these specific models during surgery are at risk.
How to tell if you have this one
Check if your implant has a size and angle listed in the product details (e.g., 7x10x25mm 5 degrees) or a specific lot number from the list provided. The recall includes both individual implants and convenience kits with specific part numbers and serial numbers.
- Brand
Alphatec- Category
Medical device
What to do — step by step
Check Your Implant Details
Review your implant's size, angle, part number, and lot number to see if it matches the recalled models listed in the notice.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 24 states.
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Iowa, Maryland, Massachusetts, Michigan, Minnesota, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Utah.
Recall timeline
FDA published this recall 52 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1065-2025 (December 15, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1065-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.