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Allogran-R®

BIOCOMPOSITES LTD · Model 800-005 · UDI-DI 50601557100202

MQV Prescription

510(k) clearances

2,073

Adverse events (45 deaths)

120

Recalls

225

Facilities

Description

Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is provided sterile for single patient use. The biodegradable, radiopaque granules/blocks are resorbed in approximately 6-12 months when used in accordance with the device labelling. Biocomposites Tri-Calcium Phosphate Bone Graft Substitute is manufactured from medical grade Tri-Calcium Phosphate. Numerous bone graft operations are undertaken every year to repair bone defects caused by surgery, tumours, trauma, infections and other damage. Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is intended for use in clinical situations where the use of autologous grafts or other bone graft substitutes maybe undesirable, due either to the risk of associated infection or unavailability. Allogran-R® resorbs and is replaced with bone during the healing process.

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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Data 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.