XTANT recalls specific Calix Lumbar Spinal Implant Systems due to potential sterilization issues from packaging changes. Affected units include various sizes and reference codes. No action is required as the risk is low.
This recall has been initiated due to a change in packaging and sterilization method to address potential risks of compromised sterilization presented by the existing configuration.
XTANT is recalling certain Calix Lumbar Spinal Implant Systems because a change in packaging and sterilization method might compromise sterilization. This could theoretically lead to infection risks if the implants are not properly sterilized before surgery.
The recall was initiated because a change in packaging and sterilization method could potentially compromise sterilization. If the implants are not properly sterilized before surgery, there is a risk of infection.
Patients who have received or are scheduled for surgery using the recalled Calix Lumbar Spinal Implant Systems are most at risk. The recall affects specific sizes and reference codes used in spinal surgery.
Check for the following reference codes: X034-0172PC, X034-0173PC, X034-0240PC, X034-0241PC, X034-0242PC, X034-0243PC, X034-0280PC, X034-0281PC, X034-0282PC, X034-0283PC, X034-0284PC, X034-0285PC, X034-0286PC, X034-0287PC, X034-0288PC, X034-0289PC, X034-0290PC, X034-0387PC, X034-0388PC, X034-0389PC, X034-0390PC, X034-0391PC, X034-0392PC, X034-0393PC, X034-0394PC, X034-0395PC, X034-0396PC. These are specific sizes used in spinal surgery.
Identify the reference code on your implant to see if it matches the recalled list.
No action is required as the risk is low. The recall is for potential sterilization issues, but the implants are safe for use if properly sterilized.
The recall states that a change in packaging and sterilization method may compromise sterilization, but no specific infection risk is mentioned in the record.
Check the reference code on your implant against the list of recalled reference codes provided in the recall notice.
We’ve drafted a message you can send XTANT to request your refund or repair — edit it as you like.
Subject: Recall Z-0790-2019 — XTANT XTANT Hello, I own a XTANT that is covered by recall Z-0790-2019 from XTANT. 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.
