Zavation recalls sterile cement delivery sets for orthopedic/spinal procedures due to potential inadequate sterilization. Affected products may pose infection risks if used without proper sterilization.
Products distributed as sterile may not have been adequately sterilized
Zavation is recalling sterile cement delivery sets used in orthopedic and spinal procedures because they may not have been properly sterilized. This could lead to infection risks if the products are used without adequate sterilization.
The products may not have been adequately sterilized, which could lead to infection risks if used without proper sterilization. This is a potential hazard for medical procedures where sterile conditions are critical.
Healthcare professionals using these sterile cement delivery sets for orthopedic or spinal procedures are most at risk. Patients receiving these procedures may also be affected if the products are not properly sterilized.
The product is labeled as '10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES STERILE' for orthopedic or spinal procedures. It was distributed as sterile products for medical use.
Look for the label '10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES STERILE' for orthopedic or spinal procedures.
The recall states that products may not have been adequately sterilized, so they are not safe to use without proper sterilization.
The recall does not specify a remedy, so you should check with Zavation for guidance.
Look for the label '10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES STERILE' for orthopedic or spinal procedures.
We’ve drafted a message you can send Zavation to request your refund or repair — edit it as you like.
Subject: Recall Z-1744-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1744-2021 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.
