BIOPSYBELL recalls RENOVA SPINE KYPHOPLASTY CANNULA and trocar tips that may not have been properly sterilized, risking infection during surgery.
Products labeled as sterile were distributed, but may not have been sterilized.
BIOPSYBELL is recalling specific spine surgery tools that may not have been sterilized properly. This could lead to infections if used in medical procedures.
Sterilization is critical for surgical tools to prevent infections. If the tools weren't properly sterilized, they could carry harmful bacteria during surgery.
Medical professionals using these tools for spine surgery are most at risk. Patients undergoing procedures with these tools could face infection.
Check for the model 'RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP', size 187 mm, 10G, and batch number 20061307.
Look for the model number, size, and batch number on the product to confirm if it's recalled.
The recall states that products labeled as sterile may not have been properly sterilized, so they are not safe for use.
The recall does not specify a remedy, so contact BIOPSYBELL directly for guidance.
Yes, because the tools may not have been properly sterilized, which could lead to infections during surgery.
We’ve drafted a message you can send BIOPSYBELL to request your refund or repair — edit it as you like.
Subject: Recall Z-1633-2021 — BIOPSYBELL BIOPSYBELL Hello, I own a BIOPSYBELL that is covered by recall Z-1633-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
