Zavation recalls ZVplasty 10G 15mm surgical kits with potential inadequate sterilization for spinal procedures. Affected units include lot 12302ZV.
Products distributed as sterile may not have been adequately sterilized
Zavation is recalling a specific surgical kit used in spinal procedures because it may not have been properly sterilized. This could lead to infections or other complications during surgery if the kit is used without proper sterilization.
The surgical kit may not have been adequately sterilized, which could lead to infections or other complications during procedures. This risk is specific to the sterile surgical environment where the kit is used.
Orthopedic and spinal surgery patients who received the ZVplasty 10G 15mm kit with lot number 12302ZV. Surgeons and surgical teams using this kit are most at risk.
Check for the lot number 12302ZV on the ZVplasty 10G 15mm kit used in spinal procedures. The product is manufactured by Zavation for orthopedic and spinal surgeries.
Look for the lot number 12302ZV on the ZVplasty 10G 15mm kit used in spinal procedures.
The recall states the product may not have been adequately sterilized, so it is not safe for use in spinal procedures without proper sterilization.
Check the lot number on the kit; if it is 12302ZV, contact Zavation for further instructions.
The affected product has the lot number 12302ZV and is used in orthopedic or spinal procedures.
We’ve drafted a message you can send Zavation to request your refund or repair — edit it as you like.
Subject: Recall Z-1761-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1761-2021 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.
