Collagen Matrix Inc FDA Recalls

3 recalls on file across devices, 0 of them Class I and 1 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was distributed under the following brand namClass IIAug 3, 2022The packaging may not be sealed, which could compromise ster	The packaging may not be sealed, which could compromise sterility.	Class IIDevices	Aug 3, 2022
RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter. REF: DUMO10125Class IIDec 13, 2021Outer packaging (outer pouch) is not sealed compromising ste	Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient inf	Class IIDevices	Dec 13, 2021
DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45Class IIDec 13, 2021Outer packaging (outer pouch) is not sealed compromising ste	Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient inf	Class IIDevices	Dec 13, 2021