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GENOSS Collagen Membrane

GENOSS CO., Ltd. · Model GCM1020 · UDI-DI 08809324765679

NPL Prescription
1
510(k) clearances
191
Adverse events
11
Recalls
55
Facilities

Description

Resorbable Dental Barrier membrane

Recalls

DateFirmReason
2019-11-05Collagen Matrix IncThe products may have been packaged with an incorrect Instructions for Use.
2019-11-05Collagen Matrix IncThe products may have been packaged with an incorrect Instructions for Use.
2019-11-05Collagen Matrix IncThe products may have been packaged with an incorrect Instructions for Use.
2019-11-05Collagen Matrix IncThe products may have been packaged with an incorrect Instructions for Use.
2019-11-05Collagen Matrix IncThe products may have been packaged with an incorrect Instructions for Use.
2019-11-05Collagen Matrix IncThe products may have been packaged with an incorrect Instructions for Use.
2019-03-19Collagen Matrix, Inc.Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box
2016-12-02Biom'upLack of sterility assurance
2012-02-28Kensey Nash CorpRecall 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
2012-02-28Kensey Nash CorpRecall 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.