Zavation recalls 10-gauge ZVplasty Biopsy Devices (REF VCF-1010) for potential inadequate sterilization during production, which could lead to infections in orthopedic procedures.
Products distributed as sterile may not have been adequately sterilized
Zavation is recalling 10-gauge ZVplasty Biopsy Devices (REF VCF-1010) used in orthopedic and spinal procedures because some units may not have been properly sterilized. This could increase infection risk during medical procedures.
The devices may not have been adequately sterilized during production, which could lead to infections if used in medical procedures. This is a risk during surgical or biopsy procedures where the device comes into contact with the body.
Healthcare professionals using the ZVplasty Biopsy Device for orthopedic or spinal procedures are most at risk. Patients undergoing these procedures may be affected if the device is not properly sterilized.
Check for the model number REF VCF-1010 on the device. The recall includes devices with lot number 20061369.
Look for the lot number 20061369 on the device packaging or label.
The recall indicates some units may not have been properly sterilized, so it's not safe to use without checking the lot number.
Check the lot number on the device; if it's 20061369, contact Zavation for instructions.
Only if the lot number is not 20061369. Otherwise, stop using it and contact Zavation.
We’ve drafted a message you can send Zavation to request your refund or repair — edit it as you like.
Subject: Recall Z-1722-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1722-2021 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.
