Zavation recalls VERTEBREX single balloon kits (lot numbers 10085ZV, 10086ZV, etc.) due to potential inadequate sterilization during manufacturing.
Products distributed as sterile may not have been adequately sterilized
Zavation is recalling VERTEBREX single balloon kits used in spinal procedures because some kits may not have been properly sterilized. This could lead to infections or other complications during medical procedures.
The kits may not have been adequately sterilized during manufacturing, which could lead to infections or other complications during medical procedures. This is a risk to patients and healthcare providers during surgery.
Medical professionals who use these kits for spinal or orthopedic procedures are affected. Patients undergoing surgery with these kits may be at risk of infection.
Check the lot numbers on the kit: 10085ZV, 10086ZV, 11205ZV, 11217ZV, 11554ZV, 11558ZV, or 11559ZV. These kits are used for spinal and orthopedic procedures.
Look for lot numbers 10085ZV, 10086ZV, 11205ZV, 11217ZV, 11554ZV, 11558ZV, or 11559ZV on the VERTEBREX single balloon kit.
The kits may not have been adequately sterilized during manufacturing, which could lead to infections or complications during medical procedures.
Check the lot number on the kit. If it matches the listed numbers, contact Zavation for further instructions.
The recall is due to potential inadequate sterilization, which could lead to infections, but not immediate serious injury in normal use.
We’ve drafted a message you can send Zavation to request your refund or repair — edit it as you like.
Subject: Recall Z-1769-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1769-2021 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.
