Biopsybell recalls sterile RENOVASpine Bone Filler 10g 1:12cm products due to potential unsterilized batches. Affected units may pose infection risks if used improperly.
Products labeled as sterile were distributed, but may not have been sterilized.
Biopsybell is recalling sterile RENOVASpine Bone Filler 10g 12cm products because some batches may not have been properly sterilized. Using these products could lead to infection risks if the material isn't sterile.
The product is labeled as sterile but may not have been properly sterilized during manufacturing. This could lead to bacterial contamination if the product is used in medical procedures without adequate sterility.
Patients who received the RENOVASpine Bone Filler 10g 12cm product with batch number 20061305 are most at risk. Healthcare providers using this product for spinal procedures may also be affected.
Check for the product name 'RENOVASpine Bone Filler 10g 12cm Sterile' with batch number 20061305. The product code is RESFIL1112C1-US.
Verify the batch number on the product label to confirm if it matches 20061305.
The product may not be sterile, so it could pose infection risks if used without proper sterilization.
Check the batch number to see if it matches 20061305. If it does, contact Biopsybell for guidance.
The recall record does not specify a replacement process or remedy.
We’ve drafted a message you can send Biopsybell to request your refund or repair — edit it as you like.
Subject: Recall Z-1632-2021 — Biopsybell Biopsybell Hello, I own a Biopsybell that is covered by recall Z-1632-2021 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.
