Zavation recalls 10-gauge cement delivery cannulas (INTVM-CDC) used in orthopedic/spinal procedures due to potential inadequate sterilization. Affected products have batch numbers 19112827 and 2002440.
Products distributed as sterile may not have been adequately sterilized
Zavation is recalling 10-gauge cement delivery cannulas used in spinal and orthopedic procedures because some may not have been properly sterilized. This could lead to infections or other health risks if the cannulas are used without being fully sterile.
The cannulas may not have been adequately sterilized during manufacturing, which could lead to infections or other health issues if used in medical procedures. This is a risk specific to sterile surgical environments where contamination could harm patients.
Healthcare professionals who use these cannulas during spinal or orthopedic surgeries are most at risk. Patients receiving these procedures may also be affected if the cannulas are not properly sterilized.
Check for batch numbers 19112827 or 2002440 on the product packaging. These are 10-gauge cement delivery cannulas (INTVM-CDC) used in orthopedic or spinal procedures.
Look for batch numbers 19112827 or 2002440 on the cannula packaging.
The products may not have been adequately sterilized, which could lead to infections or other health risks during medical procedures.
Check the batch number on the packaging. If it matches 19112827 or 2002440, contact Zavation for further instructions.
The recall is due to potential inadequate sterilization, which could lead to infections. There is no mention of immediate serious injury risks in normal use.
We’ve drafted a message you can send Zavation to request your refund or repair — edit it as you like.
Subject: Recall Z-1701-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1701-2021 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.