Zavation recalls 10G DIRECT DOUBLE BONE ACCESS KIT for orthopedic/spinal procedures due to potential inadequate sterilization. Affected items may pose infection risks.
Products distributed as sterile may not have been adequately sterilized
Zavation is recalling 10G DIRECT DOUBLE BONE ACCESS KIT surgical kits used in orthopedic and spinal procedures because some may not have been properly sterilized. This could lead to infection risks for patients during surgery.
The kits distributed as sterile may not have been adequately sterilized, meaning they could carry harmful bacteria. If used during surgery, this could lead to infections in patients.
Surgical teams and hospitals using Zavation's 10G DIRECT DOUBLE BONE ACCESS KIT for orthopedic or spinal procedures. Patients undergoing surgery with these kits may face infection risks.
Check for the product name '10G DIRECT DOUBLE BONE ACCESS KIT' used in orthopedic or spinal procedures. The recall is pending, so no specific model numbers or dates are listed.
Verify if the kit was distributed as sterile by checking the packaging or manufacturer's documentation.
The recall is for surgical kits used in orthopedic or spinal procedures. If you had surgery with this kit, contact your surgeon or hospital for guidance.
The recall applies to 10G DIRECT DOUBLE BONE ACCESS KIT kits used in orthopedic or spinal procedures. No specific model numbers or dates are listed, so check with your supplier.
The recall does not specify a stop-use action. Check with your hospital or manufacturer for further instructions.
We’ve drafted a message you can send Zavation to request your refund or repair — edit it as you like.
Subject: Recall Z-1738-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1738-2021 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.
