Zavation recalls ZVplasty 10G, 15mm Single Balloon Kits (REF VCF-SBK) used in orthopedic/spinal procedures due to potential inadequate sterilization. Affected lots include 13877ZV, 13661ZV, and others. Consumers should contact Zavation for details.
Products distributed as sterile may not have been adequately sterilized
Zavation is recalling ZVplasty 10G, 15mm Single Balloon Kits (REF VCF-SBK) used in orthopedic or spinal procedures because some products may not have been properly sterilized. This could lead to infections or other health risks if used in medical procedures.
The kits may not have been adequately sterilized, which could lead to infections or other health complications during medical procedures. This is a risk specific to surgical use where sterility is critical.
Healthcare professionals using Zavation's ZVplasty kits for orthopedic or spinal procedures are most at risk. Patients receiving these kits during surgery may also be affected if the kits were not properly sterilized.
Check the lot number on the kit packaging. Affected lots include 13877ZV, 13661ZV, 13388ZV, 12897ZV, 12764ZV, 12542ZV, 14391ZV, 14287ZV, 13004ZV, 10951ZV, and 14016ZV.
Look for the lot number on the kit packaging to determine if it is affected. Affected lots include 13877ZV, 13661ZV, 13388ZV, 12897ZV, 12764ZV, 12542ZV, 14391ZV, 14287ZV, 13004ZV, 10951ZV, and 14016ZV.
The kits may not have been adequately sterilized, which could lead to infections or other health complications during medical procedures.
Affected lots include 13877ZV, 13661ZV, 13388ZV, 12897ZV, 12764ZV, 12542ZV, 14391ZV, 14287ZV, 13004ZV, 10951ZV, and 14016ZV.
The recall does not specify a stop-use instruction; affected kits should be checked against the list of lot numbers to determine if they are unsafe.
We’ve drafted a message you can send Zavation to request your refund or repair — edit it as you like.
Subject: Recall Z-1764-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1764-2021 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.
