Zavation recalls InterV 11G Kyphoplasty Kits with specific reference numbers and lot codes due to potential inadequate sterilization, which could lead to infection risks during spinal surgery.
Products distributed as sterile may not have been adequately sterilized
Zavation is recalling certain InterV 11G Kyphoplasty Kits used in spinal procedures because they may not have been properly sterilized. This could increase the risk of infection for patients undergoing surgery.
The kits may not have been adequately sterilized, meaning they could carry harmful bacteria or pathogens. This poses a risk of infection during spinal surgery if the kits are used without proper sterilization.
Medical professionals using these kits for spinal procedures are most at risk. Patients undergoing surgery with the recalled kits could face infection risks.
Check the reference numbers: INTVMN-10-DSK, INTVMN-15-DSK, INTVMN-15-DSKC, or INTVMN-20-DSK. Look for specific lot numbers listed in the recall notice for each reference.
Identify the reference numbers from the list: a) INTVMN-10-DSK, b) INTVMN-15-DSK, c) INTVMN-15-DSKC, d) INTVMN-20-DSK.
Check the lot numbers associated with each reference number as listed in the recall notice.
The kits may not have been adequately sterilized, which could lead to infection risks during spinal surgery.
Reference numbers: a) INTVMN-10-DSK, b) INTVMN-15-DSK, c) INTVMN-15-DSKC, d) INTVMN-20-DSK.
Check the reference numbers and associated lot numbers listed 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-1755-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1755-2021 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.
