Biocomposites recalls Stimulan Kit 10cc Model 600-010 due to mislabeling. This product is intended for bone void fillers but may be used incorrectly.
The product is mislabeled.
Biocomposites is recalling its Stimulan Kit 10cc Model 600-010 because it's mislabeled. This could lead to incorrect use as a bone void filler, which might not be safe for the intended purpose.
The product is mislabeled, meaning it might not be intended for the specific bone void applications it's being used for. This could lead to improper use if the product isn't suitable for the intended purpose.
Medical professionals who use this kit for bone void fillers may be affected. Patients receiving the product could be at risk if misused.
Check for the model number 600-010 on the kit. The product was sold with lot number SK190610 and expired June 2022.
Look for the model number 600-010 and lot number SK190610 on the kit.
The recall states it's mislabeled, so it may not be safe for the intended use as a bone void filler.
The recall doesn't specify a remedy, so check the product label for the model number and lot number.
The product was sold with lot number SK190610 and expired June 2022.
We’ve drafted a message you can send Biocomposites to request your refund or repair — edit it as you like.
Subject: Recall Z-0638-2021 — Biocomposites Biocomposites Hello, I own a Biocomposites that is covered by recall Z-0638-2021 from Biocomposites. 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.
