Zavation recalls 15mm ZVplasty System (Part# VCF-1015-1) for orthopedic/spinal procedures due to potential inadequate sterilization. Affected lot numbers listed; consumers should contact Zavation for details.
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 without proper sterilization.
The products distributed as sterile may not have been adequately sterilized, which could lead to infections or other health risks if used in medical procedures without proper sterilization.
Orthopedic and spinal surgery patients or medical professionals using the ZVplasty System for procedures. Those with the listed lot numbers are most at risk.
Check the lot number on the packaging, which is listed in the recall (e.g., 13378ZV, 11141ZV). The product is a 15mm ZVplasty System used in orthopedic or spinal procedures.
Reach out to Zavation directly to confirm if your specific lot number is affected and to get instructions for next steps.
The products distributed as sterile may not have been adequately sterilized, which could lead to infections or other health risks if used in medical procedures.
Lot numbers 13378ZV, 11141ZV, 10815ZV, 13971ZV, 13921ZV, 13577ZV, 13133ZV, 13033ZV, 11793ZV, 11695ZV, 12132ZV, 14105ZV, 12280ZV, 14389ZV, 13884ZV, 11956ZV, 11470ZV, 11342ZV, 10902ZV, 10516ZV, 14358ZV, 12266ZV, 10866ZV, 10651ZV, 14207ZV, 14021ZV, 11231ZV, 11465ZV, 12025ZV, 11537ZV, 11415ZV, 10998ZV, 11072ZV, 13883ZV.
The recall does not specify a stop-use instruction; contact Zavation to determine if your specific lot number 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-1759-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1759-2021 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.
