Zavation recalls InterV 10G Kyphoplasty Kits with specific reference numbers and lot codes due to potential inadequate sterilization. This could pose a risk of infection during spinal surgery.
Products distributed as sterile may not have been adequately sterilized
Zavation is recalling certain InterV 10G Kyphoplasty Kits because they may not have been properly sterilized. This could lead to infections during spinal surgery if used without proper sterilization.
The kits may not have been adequately sterilized, which could lead to infections during spinal surgery. This is a risk if the kits are used without proper sterilization.
Orthopedic surgeons and medical professionals who use these kits for spinal procedures. Patients undergoing surgery with these kits may be at risk of infection.
Check for reference numbers: INTVM-10-DSK, INTVM-10-SBK, INTVM-15-DSK, INTVM-15-DSKC, INTVM-15-SBK, INTVM-15-SIKBC, INTVM-20-DSK, or INTVM-20-SBK. Also check the lot numbers listed for each reference.
Identify the reference number and lot number on your kit to confirm if it is recalled.
Reach out to Zavation for further guidance on the recall and potential next steps.
The kits may not have been adequately sterilized, which could lead to infections during spinal surgery.
Check the reference number and lot number to see if it is recalled. Contact Zavation for further guidance.
Yes, specific lot numbers are listed for each reference number in the recall notice.
We’ve drafted a message you can send Zavation to request your refund or repair — edit it as you like.
Subject: Recall Z-1751-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1751-2021 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.