Genex Bone Graft Substitute
BIOCOMPOSITES LTD · Model 910-005Z · UDI-DI 15060155711482
Description
genex® Bone Graft Substitute is a simple to use synthetic absorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible. The kit contains a powder filled syringe and mixing solution which, when combined, provides a mouldable cohesive paste which may be implanted into open voids/gaps of the musculoskeletal system to set in situ or placed in the bead mould mat provided to form beads for implantation. When injected the mixture sets to form genex® Bone Graft substitute a hard but absorbable matrix. genex® Bone Graft Substitute is supplied sterile. genex® Bone Graft Substitute , accessories and packaging are not made from natural rubber latex. genex® Bone Graft Substitute is MR safe.
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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