Zavation recalls 10 gauge diamond tip trocars for orthopedic/spinal procedures due to potential inadequate sterilization in sterile packaging. Affected items have specific lot numbers.
Products distributed as sterile may not have been adequately sterilized
Zavation is recalling 10-gauge diamond tip trocars used in orthopedic and spinal procedures because some may not have been properly sterilized. This could lead to infections if the device is used without adequate sterilization.
The trocars may not have been adequately sterilized, meaning they could carry harmful bacteria. If used in procedures without proper sterilization, this could lead to infections in patients.
Orthopedic and spinal surgery patients who use Zavation's 10-gauge diamond tip trocars. Surgeons and medical staff handling these devices are most at risk.
Check for the model number REF VCF-1023 on the packaging. Affected items were sold with lot numbers 2004989 or 19113039.
Look for lot numbers 2004989 or 19113039 on the packaging.
The products may not have been adequately sterilized, which could lead to infections if used without proper sterilization.
Check the lot number on the packaging. If it matches 2004989 or 19113039, contact Zavation for instructions.
The recall is for potential inadequate sterilization, not a risk of serious injury. The hazard is infection-related.
We’ve drafted a message you can send Zavation to request your refund or repair — edit it as you like.
Subject: Recall Z-1704-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1704-2021 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.
