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creos xenogain

Nibec Co., Ltd. · Model N1121-B · UDI-DI 08809186540728

NPM Prescription

510(k) clearances

113

Adverse events

Recalls

Facilities

Description

Creos xenogain is a sterile, porous bone mineral matrix produced by the removal of the organic compounds from bovine bone. The creos xenogain contains pure hydroxyapatite derived from bovine bone using a validated the manufacturing process. The large surface area of creos xenogain is effective for the regeneration of new bone around the grafted bone. The creos xenogain has good osteoconductivity to enhance new bone formation.

Recalls

Date	Firm	Reason
2022-02-02	Ace Surgical Supply Co., Inc.	NuOss Collagen (dental) was packaged with a Collatene Fibrillar Collagen(for oral wounds) rather than NuOss Collagen Block, may result in suboptimal bone repair
2020-10-19	Geistlich Pharma North America, Inc.	Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and the granules may be expelled all at once, causing surrounding tissue, particularly i
2020-10-19	Geistlich Pharma North America, Inc.	Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and the granules may be expelled all at once, causing surrounding tissue, particularly i
2020-10-19	Geistlich Pharma North America, Inc.	Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and the granules may be expelled all at once, causing surrounding tissue, particularly i
2019-04-12	Geistlich Pharma North America, Inc.	When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen.
2019-04-12	Geistlich Pharma North America, Inc.	When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen.
2019-04-12	Geistlich Pharma North America, Inc.	When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen.
2018-10-30	Collagen Matrix Inc	There is a possibility that the product labeled as 4.0cc volume may only contain 2.0cc volume and is therefore mislabeled.
2015-11-17	Collagen Matrix Inc	The distributor, Osteogenics Biomedical, notified the firm that the syringes were not working properly and the syringes were being held in quarantine.
2015-08-25	Collagen Matrix Inc	On 8/25/2015, Collagen Matrix, Inc discovered that one of the 171 units of NuOss Cancellous product shipped to a distributor may have included an incorrect size.

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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.