Zavation recalls 11-gauge ZVplasty Biopsy Devices (REF VCF-1010-11) for potential inadequate sterilization during orthopedic procedures. Affected units sold with lot number 20061370.
Products distributed as sterile may not have been adequately sterilized
Zavation is recalling 11-gauge ZVplasty Biopsy Devices used in orthopedic or spinal procedures because some units may not have been properly sterilized. This could lead to infection or other health risks if the device is used without adequate sterilization.
The device may not have been adequately sterilized, which could lead to infection or other health risks if used in procedures. Sterilization failure is a common cause of infections in medical devices.
Orthopedic and spinal surgery patients who used the recalled ZVplasty Biopsy Device (REF VCF-1010-11) with lot number 20061370. Medical professionals performing procedures with this device are most at risk.
Check for the model number REF VCF-1010-11 and lot number 20061370 on the device. The device is used in orthopedic or spinal procedures.
Look for the model number REF VCF-1010-11 and lot number 20061370 on the device.
The recall indicates some units may not have been properly sterilized, so affected devices should not be used until the manufacturer confirms safety.
Check the device for the model number REF VCF-1010-11 and lot number 20061370. If you have the recalled model, contact Zavation for guidance.
The recall record does not specify a replacement process or remedy.
We’ve drafted a message you can send Zavation to request your refund or repair — edit it as you like.
Subject: Recall Z-1723-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1723-2021 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.
