Zavation recalls 10G 10mm Double Balloon Kit (REF VCF-1010-DBK) for spinal procedures due to potential inadequate sterilization. Affected lots: 12872ZV, 12406ZV, 11934ZV.
Products distributed as sterile may not have been adequately sterilized
Zavation is recalling a specific spinal surgery kit because it might not have been properly sterilized. This could lead to infections or other health risks if used in procedures. Affected kits have specific lot numbers listed in the recall.
The kit may not have been adequately sterilized, which could lead to infections or other health issues if used during spinal or orthopedic procedures. This is a potential risk during medical procedures where sterility is critical.
Orthopedic and spinal surgery patients who received the recalled kit with lot numbers 12872ZV, 12406ZV, or 11934ZV. Surgeons using these kits for procedures are most at risk.
Check the lot number on the kit: 12872ZV, 12406ZV, or 11934ZV. The product is a 10G 10mm Double Balloon Kit used in spinal procedures, with reference number VCF-1010-DBK.
Look for lot numbers 12872ZV, 12406ZV, or 11934ZV on the kit packaging.
The recall states the kit may not have been adequately sterilized, so it is not safe to use without checking the lot number.
Check the lot number on the kit. If it matches 12872ZV, 12406ZV, or 11934ZV, contact Zavation for instructions.
The recall record does not specify a replacement process or contact information.
We’ve drafted a message you can send Zavation to request your refund or repair — edit it as you like.
Subject: Recall Z-1758-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1758-2021 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.
