RegWardenFDA facility compliance records
Company

COLLAGEN MATRIX, INC.

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

Recalls by year

FDA actions on record by year2013: 1 recalls; 2015: 2 recalls; 2018: 2 recalls; 2019: 2 recalls; 2021: 1 recalls; 2022: 1 recalls1’13’142’15’16’172’182’19’201’211’22’23’24’25’26
  • Recalls (9)

Registered facilities (3)

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. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “COLLAGEN MATRIX, INC. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9043463-collagen-matrix-inc/

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