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COLLAGEN MATRIX, INC.

United States·US-MF-000015783

Last updated September 17, 2026

Information

Country: United States
Address: 15 Thornton Rd, Oakland, United States
Website: collagenmatrix.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: (877) 540-3258
PRRC Contact: Peggy Hansen
EUDAMED SRN: US-MF-000015783
FDA FEI Number: 3008817245
DUNS Number: 176262442

Catalogue (727)

Page 1 of 15

Device	Model / Reference	Registries	Class	Status
RESODURA® matrix	DUM10125	EUDAMED	Class III	Active
ASYN Puck	JABB00025	FDA UDI	Class II	Active
TriOSS Bioactive Moldable	BA025	FDA UDI	Class II	Active
BioCORE	214-0060-ST	FDA UDI	Class II	Active
OsteoMaxx Plug	XA120	FDA UDI	Class II	Active
PlatFORM BG	45-2115	FDA UDI	Class II	Active
Stylos BA \| Strip	STYS020	FDA UDI	Class II	Active
BoneSync BioActive	ABS-3500-10	FDA UDI	Class II	Active
Profiniti	AFMP025	FDA UDI	Class II	Active
Cohealyx™	BDCDM1010-5	FDA UDI	U	Active
DuraMatrix-Onlay Plus	DMOP57	FDA UDI	Class II	Active
Salvin Fulfill	FULFILL-10x20-PKG-5	FDA UDI	Class II	Active
OssiMend® Bioactive	MCCBA1012	FDA UDI	Class II	Active
Neomem FlexPlus	NF2030	FDA UDI	Class II	Active
OSTEO-Derm Enhanced	OSTEODE15x20	FDA UDI	Class II	Active
OssiMend BLOCK	PS-MCCB2004	FDA UDI	Class II	Active
Symbios	32310002	FDA UDI	Class II	Active
Bio-Reign BioActive	BR-025	FDA UDI	Class II	Active
DuraMend™	NDM11	FDA UDI	Class II	Active
Opus Flex	71320510	FDA UDI	Class II	Active
SynOss Granules	SM5010	FDA UDI	Class II	Active
OssiMend BLOCK	MCCB0524	FDA UDI	Class II	Active
Plena Medium	PDM1520	FDA UDI	Class II	Active
naturesQue ColTect P	58496	FDA UDI	Class II	Active
TenoMend	CTW6025	FDA UDI	Class II	Active
DurAdapt	DFCS45	FDA UDI	Class II	Active
OssiMend® Bioactive \| Strip	MCCBA1012	FDA UDI	Class II	Active
X-GEN Granules	PMC2020	FDA UDI	Class II	Active
Opus Strip	71321220	FDA UDI	Class II	Active
neocote	neocote	FDA UDI	U	Active
Arthrex Nerve Wrap	ABS-12050W	FDA UDI	Class II	Active
OssiMend Block	MCCB20	FDA UDI	Class II	Active
Straumann SocketPlug	070.051	FDA UDI	Class II	Active
BVital FORM RCM	BC-F1520	FDA UDI	Class II	Active
DuraMatrix-Onlay Conform	DMOC13	FDA UDI	Class II	Active
VIA Mend Bioactive Strip	VMB0020	FDA UDI	Class II	Active
BVital FORM RCM	BC-F3040	FDA UDI	Class II	Active
Zimmer Collagen Tape	0100Z	FDA UDI	U	Active
NeuroMend	CNW6050	FDA UDI	Class II	Active
DuraMend-Onlay™ Plus	NDMOP13	FDA UDI	Class II	Active
Plena Flex	CDMPP2030	FDA UDI	Class II	Active
Profiniti Bioactive	AFBA025	FDA UDI	Class II	Active
MatrixOss Granules	PMC1010	FDA UDI	Class II	Active
Augmatrix	M600-020-10	FDA UDI	Class II	Active
OssiMend Putty	MCCP05	FDA UDI	Class II	Active
DuraMend-Onlay™	NDMO33	FDA UDI	Class II	Active
OssiMend® Bioactive \| Strip	MCCBA2012	FDA UDI	Class II	Active
SynOss Plug	SMCP0625	FDA UDI	Class II	Active
OsseoGuard Flex	OGF1520	FDA UDI	Class II	Active
TriOSS Bioactive Moldable	BA05	FDA UDI	Class II	Active

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Authorities

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FDA Recalls (15)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Aug 3, 2022	Z-1777-2022	—	open, classified	The packaging may not be sealed, which could compromise sterility.
Dec 13, 2021	Z-0668-2022	—	terminated	Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery
Dec 13, 2021	Z-0669-2022	—	terminated	Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery
Nov 5, 2019	Z-0909-2020	—	terminated	The products may have been packaged with an incorrect Instructions for Use.
Nov 5, 2019	Z-0910-2020	—	terminated	The products may have been packaged with an incorrect Instructions for Use.
Nov 5, 2019	Z-0908-2020	—	terminated	The products may have been packaged with an incorrect Instructions for Use.
Nov 5, 2019	Z-0907-2020	—	terminated	The products may have been packaged with an incorrect Instructions for Use.
Nov 5, 2019	Z-0912-2020	—	terminated	The products may have been packaged with an incorrect Instructions for Use.
Nov 5, 2019	Z-0911-2020	—	terminated	The products may have been packaged with an incorrect Instructions for Use.
Mar 19, 2019	Z-1389-2019	—	terminated	Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box
Oct 30, 2018	Z-0752-2019	—	terminated	There is a possibility that the product labeled as 4.0cc volume may only contain 2.0cc volume and is therefore mislabeled.
Aug 16, 2018	Z-0414-2019	—	terminated	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 difference between the two boxes is the product trade name. The label placed on the box and on the product packaged inside the box is correct. The Instructions for Use inside the box are correct.
Nov 17, 2015	Z-1173-2016	—	terminated	The distributor, Osteogenics Biomedical, notified the firm that the syringes were not working properly and the syringes were being held in quarantine.
Aug 25, 2015	Z-1096-2016	—	terminated	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.
May 13, 2013	Z-1097-2016	—	terminated	During the 36 month real time shelf life testing of NuOss XC Sinus (BMCU-Umbrella) to verify the 3 year shelf life designated for the device, 3 of 13 products did not pass the recovery test, which requires that the compressed product fully expand within 1 minute of hydration time.