Zavation recalls ZVplasty 10G, 20mm Traditional Unipedicular Kits (REF VCF-1020-1) due to potential inadequate sterilization. Affected lots include 13978ZV through 14349ZV. Consumers should check their kit's lot number and contact Zavation for details.
Products distributed as sterile may not have been adequately sterilized
Zavation is recalling certain ZVplasty 10G, 20mm Traditional Unipedicular Kits (REF VCF-1020-1) because they may not have been properly sterilized. This could lead to infections during orthopedic or spinal procedures if used without proper sterilization.
The kits may not have been adequately sterilized, which could lead to infections during surgical procedures. This is a risk for patients undergoing orthopedic or spinal surgeries using the recalled kits.
Orthopedic and spinal surgery patients who use these kits during procedures. The risk is low as the hazard involves potential infection from inadequate sterilization, not immediate injury.
Check the lot number on the kit, which is listed as 13978ZV through 14349ZV. The product is a ZVplasty 10G, 20mm Traditional Unipedicular Kit with reference number VCF-1020-1, used in orthopedic or spinal procedures.
Look for the lot number on the kit, which should be one of the listed numbers (13978ZV through 14349ZV).
The kits may not have been adequately sterilized, which could lead to infections during orthopedic or spinal procedures.
Check the lot number on the kit. If it matches the listed numbers, contact Zavation for instructions.
The hazard is potential infection from inadequate sterilization, not immediate injury. This is considered low risk.
We’ve drafted a message you can send Zavation to request your refund or repair — edit it as you like.
Subject: Recall Z-1765-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1765-2021 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.
