Stimulan® Rapid Cure
BIOCOMPOSITES LTD · Model 620-005 · UDI-DI 15060155711024
Description
STIMULAN® Rapid Cure provided sterile for single patient use. STIMULAN® Rapid Cure contains calcium sulfate powder and mixing solution in pre-measured quantities so that when mixed together in a sterile mixing bowl, the resultant paste is to be digitally packed into open bone void/gap to set in situ or placed into the mould provided, the mixture sets to form beads. The biodegradable, radiopaque beads are resorbed in approximately 30 – 60 days when used in accordance with the device labelling. STIMULAN® Rapid Cure is manufactured from synthetic implant grade calcium sulfate dihydrate (CaSO4.2H2O) that resorbs and is replaced with bone during the healing process. Also, as the bone void filler beads are biodegradable and biocompatible, they may be used at an infected site.
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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