Biopsybell recalls cement mixing systems for vertebroplasty-kyp-hoplasty that may not have been properly sterilized. Affected units include specific batch numbers from 2003721.
Products labeled as sterile were distributed, but may not have been sterilized.
Biopsybell is recalling cement mixing systems used for vertebroplasty-kyp-hoplasty procedures because some products labeled as sterile may not have been properly sterilized. This could lead to infection risks during medical procedures.
Products labeled as sterile were distributed but may not have been sterilized properly. This means the equipment could be contaminated with bacteria or other pathogens, increasing the risk of infection during medical procedures.
Medical professionals using the cement mixing systems for verteb:roplasty-kyp-hoplasty procedures are most at risk. Patients undergoing these procedures may also be affected if the equipment is not properly sterilized.
Check for the product name 'Cement Mixing System, Vertebroplasty-Kyphoplasty' and batch number 2003721. The recall applies to specific units sold with this batch number.
Identify the batch number on the product label to confirm if it matches 2003721.
The recall states that products labeled as sterile may not have been properly sterilized, so they are not safe for use without verification.
Check the batch number on the product label. If it matches 2003721, contact Biopsybell for further instructions.
The recall does not specify a stop-use instruction, but products with the batch number 2003721 may not be properly sterilized and should be checked for safety.
We’ve drafted a message you can send Biopsybell to request your refund or repair — edit it as you like.
Subject: Recall Z-1635-2021 — Biopsybell Biopsybell Hello, I own a Biopsybell that is covered by recall Z-1635-2021 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.
