Collagen Matrix, Inc

Activity by year

Devices registered here (1)

• Wound Dressing With Animal-Derived Material(S)
  Product code KGN (opens in a new tab) · Unclassified · Unknown

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…

FDA inspections (1)

• NAI2017-07-13
  No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (1)

• Warning Letter2016-09-20
  Warning Letter (opens in a new tab) · Allendale New Jersey

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

Related

• All facilities operated by COLLAGEN MATRIX, INC.
• COLLAGEN MATRIX, INC. (NJ)
• Collagen Matrix, Inc. (NJ)

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)