Zavation recalls InterV 10G Bone Access Tools/Kit (REF INTVM-FLNK) due to potential inadequate sterilization. This affects orthopedic/spinal surgery tools sold with lot number 11613ZV.
Products distributed as sterile may not have been adequately sterilized
Zavation is recalling InterV 10G Bone Access Tools/Kit (REF INTVM-FLNK) because some units may not have been properly sterilized. This could pose a risk of infection during spinal or orthopedic procedures if used without proper sterilization.
The tools may not have been adequately sterilized, which could lead to infections if used in surgical procedures. This is a risk during procedures where sterile conditions are critical.
Orthopedic and spinal surgery patients who use these tools during procedures. Medical professionals using the tools for surgery are most at risk.
Check for the product name 'InterV 10G Bone Access Tools/Kit' and reference number REF INTVM-FLNK. The affected lot number is 11613ZV.
Identify the product name and reference number to confirm if it matches the recalled items.
The recall states that some units may not have been adequately sterilized, so they are not safe for use without proper sterilization.
The recall record does not specify a remedy, so contact Zavation directly for guidance.
The affected lot number is 11613ZV, but the recall does not specify how to identify the lot number on the product.
We’ve drafted a message you can send Zavation to request your refund or repair — edit it as you like.
Subject: Recall Z-1754-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1754-2021 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.
