XTANT recalls Irix-A Lumbar Fusion System implants with incorrect expiration date labels. This may lead to improper use if the implant is used after its actual expiration date.
Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.
XTANT is recalling specific models of their Irix-A Lumbar Fusion System implants due to incorrect expiration date labels on some units. This could lead to improper use if the implant is used after its actual expiration date.
The implants were distributed with an incorrect expiration date label. If the implant is used after its actual expiration date, it may not be safe for the patient's surgery.
Patients who received the recalled Irix-A Lumbar Fusion System implants with incorrect expiration date labels. Surgeons and medical facilities that used these specific models are most at risk.
Check for the model numbers X080-423011-08PC or X080-382819-08PC on the implant packaging. The lot numbers 054961 or 053028 are also associated with these models.
Verify the expiration date label on the implant packaging to ensure it matches the actual expiration date.
The recalled models are X080-423011-08PC and X080-382819-08PC.
Check the expiration date label on the implant packaging to ensure it matches the actual expiration date.
The implants may not be safe if used after their actual expiration date, but the hazard is low risk as the issue is a labeling error.
We’ve drafted a message you can send XTANT to request your refund or repair — edit it as you like.
Subject: Recall Z-1177-2025 — XTANT XTANT Hello, I own a XTANT that is covered by recall Z-1177-2025 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.
