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Stimulan Kit 5cc (CHINA ONLY)

BIOCOMPOSITES LTD · Model 600-005 · UDI-DI 15060155711567

MQV Prescription

510(k) clearances

2,056

Adverse events (44 deaths)

120

Recalls

225

Facilities

Description

(CHINA ONLY) Stimulan® Calcium Sulphate Kit is provided sterile for single patient use. The Kit contains calcium sulphate powder. When the powder is mixed with sterile water in a sterile mixing bowl, the resultant paste is to be injected, digitally packed into open bone void/gap to cure in situ or placed into a mould, the mixture sets to form Stimulan® pellets. The biodegradable, radiopaque pellets are resorbed in approximately 30 - 60 days when used in accordance with the device labelling.

Recalls

Date	Firm	Reason
2026-07-02	IsoTis OrthoBiologics, Inc.	Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis, were filled with approx. 4.5 cc
2026-03-25	Orthorebirth Co Ltd	Resorbable bone void filler falls outside standard specifications.
2026-03-25	Orthorebirth Co Ltd	Resorbable bone void filler falls outside standard specifications.
2026-03-09	XTANT Medical Holdings, Inc	Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.
2025-09-02	Berkeley Advanced Biomaterials, LLC	Due to incorrect product label (Incorrect product name identified on outer packaging).
2025-04-07	SCIENCE & BIO MATERIALS	Vials of implant bone granules may contain less product then specified on labeling.
2024-11-27	IsoTis OrthoBiologics, Inc.	Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.
2024-11-27	IsoTis OrthoBiologics, Inc.	Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.
2023-12-22	Musculoskeletal Transplant Foundation, Inc.	Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.
2023-12-22	Musculoskeletal Transplant Foundation, Inc.	Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.