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Vitoss BA
Stryker Corporation · Model 2102-1605 · UDI-DI 00808232000511
MQV
Prescription
1
510(k) clearances
2,056
Adverse events (44 deaths)
120
Recalls
225
Facilities
Description
Bioactive Bone Graft Substitute, Foam Pack; Beta-Tricalcium Phosphate, Type I Bovine Collagen, and Bioactive Glass
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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Get your free API keyRead the docsData 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.