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.
Complaints have been received regarding post-operative implant collapse.
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.
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.
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.
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.
Review your implant's size, angle, part number, and lot number to see if it matches the recalled models listed in the notice.
The recall does not specify a remedy, so no action is required unless your implant matches the listed models and lot numbers.
Check your implant's size, angle, part number, and lot number against the detailed list provided in the recall notice.
The recall mentions post-operative implant collapse, which could lead to complications requiring additional surgery, but no specific injury mechanism is described.
We’ve drafted a message you can send Alphatec to request your refund or repair — edit it as you like.
Subject: Recall Z-1065-2025 — Alphatec Alphatec Hello, I own a Alphatec that is covered by recall Z-1065-2025 from Alphatec. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
