Zavation recalls 11-gauge ZVplasty Bipedicular Cement Delivery Cannulas (REF VCF-DCDK-11) due to potential inadequate sterilization in orthopedic spinal procedures.
Products distributed as sterile may not have been adequately sterilized
Zav: Zavation is recalling 11-gauge ZVplasty Bipedicular Cement Delivery Cannulas (REF VCF-DCDK-11) because some units may not have been properly sterilized. This could lead to infections during spinal or orthopedic surgery if used without proper sterilization.
The cannulas may not have been adequately sterilized, meaning they could carry harmful bacteria or contaminants. If used in spinal or orthopedic procedures without proper sterilization, this could lead to infections in patients.
Orthopedic and spinal surgery patients who use Zavation's ZVplasty Bipedicular Cement Delivery Cannulas (REF VCF-DCDK-11) for procedures. Surgeons and surgical teams are most at risk if the cannula is not properly sterilized.
Check for the model number REF VCF-DCDK-11 on the cannula. The product was distributed with lot number 19123174 for orthopedic and spinal procedures.
Look for the model number REF VCF-DCDK-11 and lot number 19123174 on the cannula.
Zavation recalls these cannulas because some units may not have been adequately sterilized, which could lead to infections during spinal or orthopedic procedures.
Check for the model number REF VCF-DCDK-11 and lot number 19123174 on the cannula.
The recall record does not specify a remedy, so contact Zavation directly for guidance.
We’ve drafted a message you can send Zavation to request your refund or repair — edit it as you like.
Subject: Recall Z-1710-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1710-2021 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.