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Regenomer

Nibec Co., Ltd. · Model RSB1-S · UDI-DI 08809186549424

NPM Prescription

510(k) clearances

113

Adverse events

Recalls

Facilities

Description

Regenomer® is a sponge-like absorbable and porous collagen designed to be used as bone filling augmentation material. The device is manufactured from purified type I collagen derived from porcine skin sources in South Korea. The porcine skin is certified by veterinarian and is obtained by a standardized controlled manufacturing process. Regenomer® is manufactured in three types, Regenomer® Syringe (sheet shape in syringe and blister), Regenomer® Plug (bullet shape in blister), and Regenomer® Block (block shape in blister). Regenomer® are supplied sterile, non-pyrogenic, and for single use only.

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.