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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 11 of 15

Device	Model / Reference	Registries	Class	Status
NeuroFlex	CNCF5025	FDA UDI	Class II	Active
UniFuze™ BA	805-0020	FDA UDI	Class II	Active
SynOss Putty	SMB050	FDA UDI	Class II	Active
neotape	neotape	FDA UDI	U	Active
Arthrex Nerve Wrap	ABS-4025W	FDA UDI	Class II	Active
PuraFLEX	YSSPF30	FDA UDI	Class II	Active
Bio-Reign™ Bioactive	BR-10	FDA UDI	Class II	Active
Profiniti Bioactive	AFBA010	FDA UDI	Class II	Active
OssiMend® Bioactive	MCCBA0503	FDA UDI	Class II	Active
OssiMend BLOCK	PS-MCCB0514	FDA UDI	Class II	Active
BoneSync BioActive	ABS-3400-02	FDA UDI	Class II	Active
SynOss Granules	SM2510	FDA UDI	Class II	Active
OssiMend BLOCK	MCCB0514	FDA UDI	Class II	Active
OssiMend	PS-MCC2020-1	FDA UDI	Class II	Active
KBIO® Dura	KBI-DU 01 03-S	FDA UDI	Class II	Active
ABIL Conformable Putty	A0507-02	FDA UDI	Class II	Active
PLENA Graft 0.5	PMC0510	FDA UDI	Class II	Active
ABIL Putty	A0506-03	FDA UDI	Class II	Active
OssiMend BLOCK	PS-MCCB1004	FDA UDI	Class II	Active
NeuroMatrix	CNC6025	FDA UDI	Class II	Active
CollaShield	CS15x20	FDA UDI	Class II	Active
Plena Medium	PDM3040	FDA UDI	Class II	Active
BoneSync BioActive	ABS-3400-02	FDA UDI	Class II	Active
ASYN Strip	JABB00100	FDA UDI	Class II	Active
OssiMend Bioactive Moldable	MCCBA025	FDA UDI	Class II	Active
DuraMatrix Onlay	CDSLM33	FDA UDI	Class II	Active
Plena Medium	PDM2030	FDA UDI	Class II	Active
StarGraft Granules	SGG100	FDA UDI	Class II	Active
NeoGenix XP Syringe	64098	FDA UDI	Class II	Active
VENADO Carbonate Apatite Sponge	4817-T25102	FDA UDI	Class II	Active
BioCORE	214-0025-BK	FDA UDI	Class II	Active
KBIO® Dura	KBI-DU 04 05-S	FDA UDI	Class II	Active
DuraMatrix Onlay	CDSLM45	FDA UDI	Class II	Active
TenoMend	CTW16025	FDA UDI	Class II	Active
TriOSS Bioactive Moldable	BA2025	FDA UDI	Class II	Active
OssiMend	MCC2020	FDA UDI	Class II	Active
Neogen Collagen Firm M	64056	FDA UDI	Class II	Active
X-Flex	CDMPP1520	FDA UDI	Class II	Active
MatrixDerm	PDM2030	FDA UDI	Class II	Active
X-GEN Syringe	PMCS05	FDA UDI	Class II	Active
SynOss Granules	SM20010	FDA UDI	Class II	Active
OssiGuide	OG10	FDA UDI	Class II	Active
PuraEXTEND	YSSPE15	FDA UDI	Class II	Active
contour BA	CBA-1000	FDA UDI	Class II	Active
OssiGuide	OG05	FDA UDI	Class II	Active
MaxxDerm	XD304	FDA UDI	Class II	Active
NeoGen Plug	64062	FDA UDI	U	Active
OssiMend Bioactive Moldable	MCCBA05	FDA UDI	Class II	Active
MaxxMem	XC152	FDA UDI	Class II	Active
Opus™ BA Strip	71422540	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.