Biocomposites Stimulan Kit 10cc Model 60: Mislabeled Bone Void Filler
Biocomposites recalls Stimulan Kit 10cc Model 600-010 due to mislabeling. This product is intended for bone void fillers but may be used incorrectly.
Lower-risk recall
The product is mislabeled.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/63929-biocomposites-stimulan-kit-10cc-model-60-mislabeled-bone-void-filler.
Source Summary by GovInfoNow · govinfonow.com/recall/63929-biocomposites-stimulan-kit-10cc-model-60-mislabeled-bone-void-filler · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0638-2021
Cite this page
“Biocomposites Stimulan Kit 10cc Model 60: Mislabeled Bone Void Filler.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63929-biocomposites-stimulan-kit-10cc-model-60-mislabeled-bone-void-filler. Based on FDA recall #Z-0638-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0638-2021%22&limit=1).
Why it’s dangerous
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.
Who’s affected
Medical professionals who use this kit for bone void fillers may be affected. Patients receiving the product could be at risk if misused.
How to tell if you have this one
Check for the model number 600-010 on the kit. The product was sold with lot number SK190610 and expired June 2022.
- Brand
Biocomposites- Category
Medical device
What to do — step by step
Check Product Label
Look for the model number 600-010 and lot number SK190610 on the kit.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide in the Puerto Rico and the country of Costa Rica.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 5 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-0638-2021 (November 12, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0638-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.