Zavation recalls ZVplasty Direct Access Diamond Tip Trocar (11 Gauge, REF VCF-1023-11) for orthopedic/spinal procedures due to potential inadequate sterilization. Affected items may not be sterile, risking infection.
Products distributed as sterile may not have been adequately sterilized
Zavation is recalling its ZVplasty Direct Access Diamond Tip Trocar (11 Gauge, REF VCF-1023-11) used in orthopedic or spinal procedures because some products may not have been properly sterilized. This could lead to infections if used in medical procedures.
The trocar may not have been adequately sterilized, meaning it could carry harmful bacteria or other contaminants. If used in surgical procedures, this could lead to infections in patients or healthcare workers.
Healthcare professionals using this trocar for orthopedic or spinal procedures are most at risk. Patients receiving the device during surgery could be affected if the product wasn't properly sterilized.
Check for the model number REF VCF-1023-11 on the trocar. Products were sold with lot numbers 19123264 or 20071773.
Look for lot numbers 19123264 or 20071773 on the trocar packaging or device.
The recall states that products distributed as sterile may not have been adequately sterilized, so they are not safe for use in medical procedures.
Check for the model number REF VCF-1023-11 and lot numbers 19123264 or 20071773.
The recall does not specify a remedy, so contact Zavation directly for guidance.
We’ve drafted a message you can send Zavation to request your refund or repair — edit it as you like.
Subject: Recall Z-1712-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1712-2021 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.