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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 7 of 15

Device	Model / Reference	Registries	Class	Status
OssiMend Putty	PS-MCCP02	FDA UDI	Class II	Active
PARASORB RESODONT Flex	RDC3040	FDA UDI	Class II	Active
MatrixOss Syringe	PMCS025	FDA UDI	Class II	Active
OSTEO-Flex	OSTEOF30x40	FDA UDI	Class II	Active
BIA-GEN Bioactive	CS-MCCBA-070	FDA UDI	Class II	Active
Profiniti	AFP02	FDA UDI	Class II	Active
Cohealyx™	BDCDM24-5	FDA UDI	U	Active
BVital GENOSS Syringe	BS-GS005	FDA UDI	Class II	Active
MatrixMem	CMPT3040	FDA UDI	Class II	Unknown
UniFuze™ BA	805-0010	FDA UDI	Class II	Active
OssiMend BLOCK	PS-MCCB0524	FDA UDI	Class II	Active
StarDerm 9-12	SD1520	FDA UDI	Class II	Active
MatrixDerm	PDM3040	FDA UDI	Class II	Active
BoneSync BioActive	ABS-3500-20	FDA UDI	Class II	Active
NeuroMend	CNW12025	FDA UDI	Class II	Active
Mem-Lok	RCM-ML3040	FDA UDI	Class II	Active
DuraMend-Onlay™	NDMO13	FDA UDI	Class II	Active
Profiniti Bioactive	AFMS020	FDA UDI	Class II	Active
RegenerOss Synthetic	ROSBGP10	FDA UDI	Class II	Active
OssiMend BLOCK	PS-MCCB20	FDA UDI	Class II	Active
Arthrex Nerve Conduit	ABS-3025C	FDA UDI	Class II	Active
SynOss Putty	SMB200	FDA UDI	Class II	Active
Plena Flex	CDMPP3040	FDA UDI	Class II	Active
Profiniti	AFMP050	FDA UDI	Class II	Active
MaxxMem	XC304	FDA UDI	Class II	Active
PlatFORM CM Block	CM25505	FDA UDI	Class II	Active
MatrixMem	CMPT3040	FDA UDI	Class II	Active
Opus™ BA Putty	71410314	FDA UDI	Class II	Active
Neodent® Membrane Flex™	NAMND070.008	FDA UDI	Class II	Active
SynOss Granules	SM10010	FDA UDI	Class II	Active
NeuroMend	CNW4025	FDA UDI	Class II	Active
MatrixDerm	PDM1520	FDA UDI	Class II	Active
StarGraft Putty	SGP050	FDA UDI	Class II	Active
Arthrex Nerve Conduit	ABS-2525C	FDA UDI	Class II	Active
DuraMatrix Onlay	CDSLM13	FDA UDI	Class II	Active
BVital FORM RCM	BC-F2030	FDA UDI	Class II	Active
BioCORE	214-0120-ST	FDA UDI	Class II	Active
DuraMend-Onlay™	NDMO57	FDA UDI	Class II	Active
StarMem 4-6	SM2030	FDA UDI	Class II	Active
TenoMend	CTW12025	FDA UDI	Class II	Active
Stratofuse	BA48-000040	FDA UDI	Class II	Active
PuraFILL	PFPLG1020	FDA UDI	Class II	Active
Profiniti	AFP10	FDA UDI	Class II	Active
Augmatrix	M640-120-10	FDA UDI	Class II	Active
Cohealyx™	BDCDM1020-5	FDA UDI	U	Active
PuraTAPE	YSSTPE	FDA UDI	U	Active
Stylos BA Strip	STYS010	FDA UDI	Class II	Active
NeuroFlex	CNCF3025	FDA UDI	Class II	Active
Opus Strip	71320605	FDA UDI	Class II	Active
TBS Bone Plug	TBSRGN11	FDA UDI	Class II	Active

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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.