BIOPSYBELL recalls CEMIX vertebroplasty cement mixers due to potential unsterilized products. Affected units may pose infection risks if used without proper sterilization.
Products labeled as sterile were distributed, but may not have been sterilized.
BIOPSYB: The company recalls its CEMIX cement mixing system for vertebroplasty and kyphoplasty procedures because some units may not have been properly sterilized. Using these products could lead to infections if they are not sterile.
The recall states that products labeled as sterile may not have been sterilized during manufacturing. This could lead to infections if the equipment is used without proper sterilization.
Medical professionals using the CEMIX system for spinal procedures are most at risk. Patients undergoing these treatments may be affected if the equipment is not properly sterilized.
Check for the product number KVTMIXN on the CEMIX system. The batch number 19123253 is associated with the affected units.
Verify if the unit was sterilized by checking the product label for the batch number 19123253.
The recall states that products labeled as sterile may not have been sterilized during manufacturing.
The official notice does not specify a remedy or action steps for affected units.
The recall does not mention a risk of serious injury; it focuses on potential infection risks from unsterilized products.
We’ve drafted a message you can send BIOPSYBELL to request your refund or repair — edit it as you like.
Subject: Recall Z-1631-2021 — BIOPSYBELL BIOPSYBELL Hello, I own a BIOPSYBELL that is covered by recall Z-1631-2021 from BIOPSYBELL. 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.
