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OSferion

OSFERIONBIOMATERIALS CORP. · Model AR-13370-1 · UDI-DI 04560245656883

MQV Prescription

510(k) clearances

2,056

Adverse events (44 deaths)

120

Recalls

225

Facilities

Description

OSferion is a white porous material composed of β-tricalcium phosphate. It is intended to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. OSferion is to be used as a bone replacement material and has properties that allow it to be replaced by autogenous bone after implantation. The porosity of OSferion is 60%. Products are supplied in wedges and trapezoids.

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.