Collage Osteoconductive Scaffold - Putty
Integra Lifesciences Corporation · Model 710010 · UDI-DI 10381780114345
Description
The Orthofix Collage Osteoconductive Scaffold - Putty (Orthofix Collage Putty) is a resorbable bone void filler made from a porous highly purified collagen matrix that has high purity tricalcium phosphate (TCP) granules dispersed throughout. The implant is provided sterile, nonpyrogenic, for single use in double peel packages. The Orthofix Collage Putty bone grafting construct is designed to facilitate the repair of bony defects. In the dry state, the matrix has a three dimensional trabecular network of pores that resembles the pore structure of human cancellous bone. The Orthofix Collage Putty quickly imbibes fluids, making it easy to combine with bone marrow aspirate. The Orthofix Collage Putty guides the regeneration of bone across the defect site into which the Putty is implanted. New bone forms in apposition to the matrix surface when the graft is placed in direct contact with viable host bone. Ultimately the matrix is resorbed and remodeled into bone.
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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