Zavation recalls 11G Direct Double Bone Access Kits for orthopedic/spinal procedures due to potential inadequate sterilization. Affected kits may not be sterile, risking infection during surgery.
Products distributed as sterile may not have been adequately sterilized
Zavation is recalling 11G Direct Double Bone Access Kits used in orthopedic and spinal procedures because some kits may not have been properly sterilized. This could lead to infections during surgery if the kits are used without being fully sterile.
The kits may not have been adequately sterilized, meaning they could carry harmful bacteria. If used in surgery without proper sterilization, this could lead to infections in patients.
Orthopedic and spinal surgery patients who use these kits during procedures. Surgeons and medical staff handling the kits are at risk if the kits are not properly sterilized.
The 11G Direct Double Bone Access Kit is used in orthopedic and spinal procedures. It was distributed by Zavation and is pending recall.
Ensure the kit has been properly sterilized before use by checking for a sterilization date and label.
The recall states that some kits may not have been adequately sterilized, so they are not safe for use without proper sterilization.
The 11G Direct Double Bone Access Kit used in orthopedic and spinal procedures distributed by Zavation is affected.
The recall does not specify a remedy, so check with Zavation for guidance on safe use or disposal.
We’ve drafted a message you can send Zav: 11G Direct Double Bone Access Kit to request your refund or repair — edit it as you like.
Subject: Recall Z-1739-2021 — Zav: 11G Direct Double Bone Access Kit Zav: 11G Direct Double Bone Access Kit Hello, I own a Zav: 11G Direct Double Bone Access Kit that is covered by recall Z-1739-2021 from Zav: 11G Direct Double Bone Access Kit. 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.
