Zavation recalls 10-gauge cement delivery cannulas (INTVM-CDC) for orthopedic/spinal procedures due to potential inadequate sterilization. Affected lots: 19112827, 2002440.
Products distributed as sterile may not have been adequately sterilized
Zavation is recalling 10-gauge cement delivery cannulas used in orthopedic and spinal procedures because some may not have been properly sterilized. This could lead to infections or other complications if used without adequate sterilization.
The cannulas distributed as sterile may not have been adequately sterilized, which could lead to infections or other complications if used in medical procedures. This is a risk during surgical procedures where the device comes into contact with the body.
Healthcare professionals using these cannulas in orthopedic or spinal procedures are most at risk. Patients receiving these procedures may be affected if the cannula is not properly sterilized.
Check for the model code INTVM-CDC on the cannula. Affected lots are 19112827 and 2002440. These are used in orthopedic and spinal procedures.
Look for the lot numbers 19112827 or 2002440 on the cannula packaging.
The recall states that products distributed as sterile may not have been adequately sterilized, so they are not safe to use without verification.
The recall does not specify a remedy, so contact Zavation directly for guidance.
The hazard is described as potential inadequate sterilization, which could lead to infections, but the recall does not indicate a risk of serious injury 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-1718-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1718-2021 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.
