Zavation recalls 11-gauge ZVplasty Direct Access Diamond Tip Trocar (REF VCF-1023-11) for orthopedic/spinal procedures due to potential inadequate sterilization. Affected units sold in 2007-2008.
Products distributed as sterile may not have been adequately sterilized
Zavation is recalling 11-gauge ZVplasty Direct Access Diamond Tip Trocars used in orthopedic or spinal procedures because some products may not have been properly sterilized. This could lead to infections or other health risks if used without proper sterilization.
The trocar may not have been adequately sterilized during manufacturing, which could lead to infections or other health risks if used in surgical procedures. This is a potential contamination hazard rather than an immediate physical danger.
Orthopedic and spinal surgery patients who used the recalled trocar (REF VCF-1023-11) between 2007 and 2008. Surgeons and medical staff handling these products are most at risk.
Check for the model number REF VCF-1023-11 on the trocar. Products were sold between 2007 and 2008 with lot numbers 19123264 or 20071773.
Identify the model number REF VCF-1023-11 and lot numbers 19123264 or 20071773 to confirm if your trocar is affected.
The recall states that products distributed as sterile may not have been adequately sterilized, so they are not safe for use without proper verification.
Check for the model number REF VCF-1023-11 and lot numbers 19123264 or 20071773 on the product.
The recall record does not specify a return or disposal action, so no immediate action is required beyond checking product details.
We’ve drafted a message you can send Zavation to request your refund or repair — edit it as you like.
Subject: Recall Z-1728-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1728-2021 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.
