Zavation recalls Vertebrx single balloon kits (lot 11553ZV, 12276ZV, 9965ZV) due to potential inadequate sterilization in spinal procedures.
Products distributed as sterile may not have been adequately sterilized
Zavation is recalling specific Vertebrx single balloon kits used in spinal procedures because they may not have been properly sterilized. This could lead to infections or other complications during medical procedures.
The kits may not have been adequately sterilized, which could lead to infections or other complications during medical procedures. This is a risk specific to surgical environments where sterile conditions are critical.
Healthcare professionals using the recalled kits for spinal or orthopedic procedures. Patients undergoing these surgeries are at risk if the kits were used without proper sterilization.
Check for lot numbers 11553ZV, 122:76ZV, or 9965ZV on the kit packaging. The product is a single balloon kit used in spinal or orthopedic procedures.
Look for lot numbers 11553ZV, 12276ZV, or 9965ZV on the product packaging.
The kits may not have been adequately sterilized, which could lead to infections or complications during spinal or orthopedic procedures.
Lot numbers 11553ZV, 12276ZV, and 9965ZV.
No specific stop-use instruction is provided; check the lot number to determine if your kit is affected.
We’ve drafted a message you can send Zavation to request your refund or repair — edit it as you like.
Subject: Recall Z-1770-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1770-2021 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.
