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GuidOss

Nibec Co., Ltd. · Model GDS 5-2010 · UDI-DI 08809186541237

NPL Prescription

510(k) clearances

191

Adverse events

Recalls

Facilities

Description

GuidOss is made from pure Type I porcine collagen membrane. It is a resorbable collagen membrane for guided tissue and bone regenerations. The Type I collagen is obtained from porcine skin purified to avoid immunological reactions. The GuidOss membrane is manufactured by fibrillogenesis and glycation with sugar (ribose). The collagen fibers are self-assembled by the process of fibrillogenesis. The glycation is a natural process of cross-linking of collagen occurring in vivo. The glycated collagen fibers exhibit increased mechanical strength, thermal stability and increased resistance to pepsin digestion compared to non-glycated collagen.

Recalls

Date	Firm	Reason
2019-11-05	Collagen Matrix Inc	The products may have been packaged with an incorrect Instructions for Use.
2019-11-05	Collagen Matrix Inc	The products may have been packaged with an incorrect Instructions for Use.
2019-11-05	Collagen Matrix Inc	The products may have been packaged with an incorrect Instructions for Use.
2019-11-05	Collagen Matrix Inc	The products may have been packaged with an incorrect Instructions for Use.
2019-11-05	Collagen Matrix Inc	The products may have been packaged with an incorrect Instructions for Use.
2019-11-05	Collagen Matrix Inc	The products may have been packaged with an incorrect Instructions for Use.
2019-03-19	Collagen Matrix, Inc.	Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box
2016-12-02	Biom'up	Lack of sterility assurance
2012-02-28	Kensey Nash Corp	Recall has been initiated due to concerns regarding the sterility of the product. The firm initiated the recall because of use of inadequately sterilized product might result in pa
2012-02-28	Kensey Nash Corp	Recall has been initiated due to concerns regarding the sterility of the product. The firm initiated the recall because of use of inadequately sterilized product might result in pa

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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.