Zavation recalls ZVplasty 10mm spinal implants (lot numbers 13403ZV, 14172ZV, etc.) due to potential inadequate sterilization. Affected items may pose infection risks during surgery.
Products distributed as sterile may not have been adequately sterilized
Zavation is recalling its ZVplasty 10mm spinal implants because some units may not have been properly sterilized. This could lead to infections during surgery if used on patients.
The products may not have been adequately sterilized, which could lead to infections during surgical procedures. This is a risk specific to medical implants used in spinal and orthopedic surgeries.
Orthopedic and spinal surgery patients who received the recalled ZVplasty 10mm implants. Surgeons and hospitals using the affected lot numbers are most at risk.
Check for the product name 'ZVplasty System, 10mm' with patent number VCF-1010-2. Affected items have lot numbers: 13403ZV, 14172ZV, 13723ZV, 13031ZV, or 10760ZV.
Look for lot numbers 13403ZV, 14172ZV, 13723ZV, 13031ZV, or 10760ZV on the packaging.
The products may not have been adequately sterilized, which could lead to infections during surgery.
Check the lot number on the packaging. If it matches the affected numbers, contact Zavation for guidance.
The recall is due to potential infection risk during surgery, not direct injury from the product itself.
We’ve drafted a message you can send Zavation to request your refund or repair — edit it as you like.
Subject: Recall Z-1757-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1757-2021 from Zavation. 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.
