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Shefabone™

SHEFABONE INC · Model SCPC Granules · UDI-DI 05060517850005

LYC Prescription

510(k) clearances

513

Adverse events (1 deaths)

Recalls

Facilities

Description

Silica-Calcium Phosphate Composite (SCPC) is a synthetic resorbable osteoconductive bone graft substitute composed of two phases: sodium calcium phosphate (NaCaPO4) and silica (SiO2). The two phases are sintered together in the form of solid solutions.The SCPC is in the form of porous particles in the size range 90-710 micron.The device is sterlized by Gama radiation.

Recalls

Date	Firm	Reason
2018-08-16	Collagen Matrix, Inc.	There is a possibility that the product was packaged in the wrong box. Specifically, the product may have been placed inside a BioMend box instead of a BioMend Extend box. The only
2016-09-07	Osteogenics Biomedical, Inc.	The device has the potential to be packaged in the wrong product box.
2016-01-21	Biomet France SARL	Cytotoxicity tests were not passed at 36 months. Use of Endobon-Xenograft Granules past 18 months of its specified shelf life may result in patient illness/injury.
2013-10-03	Biomet 3i, LLC	Individual pieces of a batch of Biomet's Endobon Xenograft Granules 0.5 ML (Bovine Bone substitute) may have an incorrect label with the wrong batch number.
2013-03-28	Integra LifeSciences Corporation	Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
2013-03-28	Integra LifeSciences Corporation	Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
2013-03-28	Integra LifeSciences Corporation	Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
2012-10-25	Kerr Corporation	The firm initiated the recall becaue disturbing the BioPlant product soon after it is placed may halt or delay the ossification process.
2012-01-11	Cytophil, Inc	Cytophil Corporation is recalling Periophil Biphasic Periophil Biphasic, Periobase Biphasic, and Periobone Biphasic because devices were inadvertently shipped after receiving an in
2010-05-14	Ace Surgical Supply Co., Inc.	Fast set 4% potassium sulfate solution may not be sterile. For customers who have used the Calcium Sulfate Hemihydrate kit without the Fast Set solution, then these potential risk

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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.