Zavation recalls ZVplasty Direct Access Bevel Tip Trocar (11 Gauge, REF VCF-1022-11) 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 ZVplasty Direct Access Bevel Tip Trocars 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 products may not have been adequately sterilized during manufacturing. This means they could become contaminated and cause infections if used in medical procedures without proper sterilization.
Healthcare professionals using Zavation's ZVplasty Direct Access Bevel Tip Trocar (11 Gauge, REF VCF-1022-11) for orthopedic or spinal procedures. Patients undergoing these procedures are at risk if the trocar is not properly sterilized.
Check for the model number REF VCF-1022-11 on the trocar. Products were sold with lot numbers 19123263, 20061381, or 20071771.
Look for lot numbers 19123263, 20061381, or 20071771 on the trocar packaging or label.
The products may not have been adequately sterilized, which could lead to infections if used in medical procedures.
Check the lot number on the trocar. If it matches 19123263, 20061381, or 20071771, contact Zavation for instructions.
The recall is due to potential inadequate sterilization, not a risk of injury from the device itself. The hazard is infection risk, not physical harm.
We’ve drafted a message you can send Zavation to request your refund or repair — edit it as you like.
Subject: Recall Z-1711-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1711-2021 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.
