Zavation recalls ZVPlasty 11G 15mm Bipedicular Kit (REF VCF-1115-2) due to potential inadequate sterilization. Affected lots include 11958ZV, 14393ZV, 11726ZV, 11107ZV, 10955ZV. This could pose infection risks during spinal surgery.
Products distributed as sterile may not have been adequately sterilized
Zavation is recalling its ZVPlasty 11G 15mm Traditional Bipedicular Kit (REF VCF-1115-2) because some units may not have been properly sterilized. This could lead to infections during spinal or orthopedic surgeries if used without proper sterilization.
The kit is designed for sterile surgical use, but some units may not have been adequately sterilized. If used without proper sterilization, this could lead to infections during procedures.
Orthopedic and spinal surgery patients and medical professionals who use the ZVPlasty kit. Those with the specific lot numbers listed are most at risk.
Check the lot number on the kit packaging. Affected lots are 11958ZV, 14393ZV, 11726ZV, 11107ZV, and 10955ZV. The product is labeled as a ZVPlasty 11G 15mm Traditional Bipedicular Kit for orthopedic/spinal procedures.
Look for the lot number on the kit packaging to determine if it is affected.
The recall is due to potential inadequate sterilization of some units, which could lead to infection risks during spinal or orthopedic surgeries.
Affected lot numbers are 11958ZV, 14393ZV, 11726ZV, 11107ZV, and 10955ZV.
The recall does not require immediate discontinuation; check the lot number to see 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-1767-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1767-2021 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.
