Synthetic Backfill Bioimplant Ø6.5 x 40mm
BERKELEY ADVANCED BIOMATERIALS, LLC · Model MSBG6540 · UDI-DI 00816125024704
Description
The Synthetic Backfill Bioimplant is designed as a bone void filler, incorporating a collagen matrix enriched with hydroxyapatite (HA) and tri-calcium phosphate (TCP) granules, along with 45S5 bioactive glass granules. This implant utilizes biocompatible bovine fibrillar collagen and bioactive 45S5 glass particles. The granular composition includes 60 wt% HA and 40 wt% TCP, with the graft containing 20 wt% of 45S5 granules. This device serves as a scaffold to facilitate new bone growth. A sequence of surface reactions on the granules leads to the creation of a calcium phosphate layer that closely mimics the composition and structure of bone mineral hydroxyapatite. This layer, along with the HA-TCP granules, forms an osteoconductive scaffold that supports the growth of the patient’s new bone. As healing progresses, the graft material is gradually absorbed and transformed into new 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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