Zavation recalls 10G Double Cement Delivery Kits (8 fillers) 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 Double Cement Delivery Kits (8 fillers) used in orthopedic and spinal procedures because some kits may not have been properly sterilized. This could lead to infection risks for patients during surgery.
The kits may not have been adequately sterilized during manufacturing, which could lead to contamination. If used in surgical procedures, this might introduce infections into the patient's body.
Medical professionals using these kits for orthopedic or spinal procedures are most at risk. Patients undergoing surgery with the recalled kits could face infection.
Check for the 10G Double Cement Delivery Kit (8 fillers) with the brand Zavation. These kits are used in orthopedic and spinal procedures.
Look for the 10G Double Cement Delivery Kit (8 fillers) with Zavation branding for orthopedic or spinal procedures.
The kits may not have been adequately sterilized during manufacturing, which could lead to infection risks during surgical procedures.
Check for the 10G Double Cement Delivery Kit (8 fillers) with Zavation branding used in orthopedic or spinal procedures.
The recall record does not specify a remedy, so contact Zavation directly for guidance.
We’ve drafted a message you can send Zavation to request your refund or repair — edit it as you like.
Subject: Recall Z-1741-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1741-2021 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.
