Facility

Collagen Matrix, Inc.

9 recall(s) on record — most severe on record: Class II.

Key facts

9recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3027448274
Establishment type	Repack or Relabel Medical Device
Location	10 Industrial Ave Mahwah, NJ, US 07430
Registration status	Active · expires 2026
Parent company	COLLAGEN MATRIX, INC. (owner-operator 9043463)
Brand names	Matrixflex; X-FLEX

Activity by year

Recalls (9)

Devices registered here (1)

Barrier, Animal Source, Intraoral
Product code NPL (opens in a new tab) · Class II · Dental · 21 CFR 872.3930

Recalls & enforcement

Class IIOngoing2022-08-03
The packaging may not be sealed, which could compromise sterility.
Class IITerminated2021-12-13
Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery
Class IITerminated2019-11-05
The products may have been packaged with an incorrect Instructions for Use.
Class IITerminated2019-03-19
Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box
Class IIITerminated2018-10-30
There is a possibility that the product labeled as 4.0cc volume may only contain 2.0cc volume and is therefore mislabeled.
Class IIITerminated2018-08-16
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 t…
Class IIITerminated2015-11-17
The distributor, Osteogenics Biomedical, notified the firm that the syringes were not working properly and the syringes were being held in quarantine.
Class IITerminated2015-08-25
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.
Class IITerminated2013-05-13
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…

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Collagen Matrix, Inc. (FEI 3027448274) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3027448274-collagen-matrix-inc/

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