Zavation recalls ZVplasty 10G and FLEX KYPHOPLASTY spinal implants due to potential inadequate sterilization. Affected lots: 14522ZV, 12260ZV, 12896ZV, 11557ZV.
Products distributed as sterile may not have been adequately sterilized
Zavation is recalling certain spinal implants (ZVplasty 10G and FLEX KYPHOPLASTY) because they may not have been properly sterilized. This could lead to infections or other complications if used in surgery.
The implants may not have been adequately sterilized, which could lead to infections or other complications during surgery. This is a risk specific to medical procedures where sterile equipment is critical.
Orthopedic surgeons and medical professionals who use these implants in spinal procedures. Patients undergoing surgery with these specific implants are at risk if the implants were not properly sterilized.
Check for lot numbers 14522ZV, 12260ZV, 12896ZV, or 11557ZV on the packaging. These are the specific lots affected by the recall.
Look for lot numbers 14522ZV, 12260ZV, 12896ZV, or 11557ZV on the implant packaging.
The recall indicates a potential risk of inadequate sterilization, so they should not be used until the recall is addressed.
Check the lot numbers on the packaging. If they match the affected lots, contact Zavation for further instructions.
Look for lot numbers 14522ZV, 12260ZV, 12896ZV, or 11557ZV on the packaging. If they match, it is affected.
We’ve drafted a message you can send Zavation to request your refund or repair — edit it as you like.
Subject: Recall Z-1763-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1763-2021 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.
