Zavation recalls certain InterV 10G FLEX Kyphoplasty devices due to potential inadequate sterilization. Affected units include specific REF and lot numbers for spinal procedures.
Products distributed as sterile may not have been adequately sterilized
Zavation is recalling specific InterV 10G FLEX Kyphoplasty devices used in spinal procedures because they may not have been properly sterilized. This could pose a risk of infection or other complications during medical use.
The devices may not have been adequately sterilized, which could lead to infections or other complications during spinal surgery. This is a potential risk for patients and medical staff handling the devices.
Medical professionals using these devices for spinal procedures. Patients undergoing surgery with the recalled devices are at risk of infection.
Check for REF numbers: INTVM-15-FLDSK or INTVM-20-FLDSK. Look for specific lot numbers listed in the recall notice for each reference.
Verify your device's lot number against the listed numbers for INTVM-15-FLDSK or INTVM-20-FLDSK to confirm if it is affected.
The recall states that products distributed as sterile may not have been adequately sterilized, so they are not safe for use until the recall is addressed.
Check your device's lot number against the list provided in the recall notice to determine if it is affected.
The recall notice does not specify a replacement process or remedy.
We’ve drafted a message you can send Zavation to request your refund or repair — edit it as you like.
Subject: Recall Z-1752-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1752-2021 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.
