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Foundation®

OLYMPUS TERUMO BIOMATERIALS CORP. · Model 27-500-200 · UDI-DI 04560245656814

LYC Prescription

510(k) clearances

512

Adverse events (1 deaths)

Recalls

Facilities

Description

Collagen-Based Bone Filling Augmentation Material./ Product Overview: FOUNDATION is made of absorbable atelo-collagen. The atelo-collagen has been cross-linked by heat treatment in order to achieve biocompatibility. FOUNDATION is provided in bullet shapes. The collagen (liquid form) suspension is pored into a bullet shape mold. The design of the bullet shape is to permit easy placement into the extraction socket. It consists of fibrillar and heat-denatured atelo-collagen. Fibrillar atelo-collagen provides scaffolding for surrounding cells and the heat-denatured atelo-collagen stimulates infiltration of the cells in the product. Contents are sterile and non-pyrogenic.

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.