Zavation recalls 15mm ZVplasty System (Part# VCF-1015-1) for orthopedic/spinal procedures due to potential inadequate sterilization. Affected lot numbers include 13378ZV through 14358ZV.
Products distributed as sterile may not have been adequately sterilized
Zavation is recalling its 15mm ZVplasty System for orthopedic and spinal procedures because some units may not have been properly sterilized. This could lead to infections or other health risks if used in medical procedures.
The product is distributed as sterile but may not have been adequately sterilized. This means the items could contain harmful bacteria or contaminants that might cause infections during medical procedures.
Orthopedic and spinal surgery patients who use the ZVplasty System. Medical professionals handling the recalled product are at risk if they use it without proper sterilization checks.
Check for the part number VCF-1015-1 on the product. Affected units have lot numbers starting with 13378ZV through 14358ZV.
Look for the lot number on the product packaging or label to determine if it is affected.
The product may not have been adequately sterilized, which could lead to infections during medical procedures.
Check the lot number on the product to see if it is affected. If it is, contact Zavation for further instructions.
Yes, the product may contain harmful bacteria or contaminants that could cause infections during medical procedures.
We’ve drafted a message you can send Zavation to request your refund or repair — edit it as you like.
Subject: Recall Z-1760-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1760-2021 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.
