Collagen Matrix, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0668-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45

Product Classification:

Class II

Date Initiated: December 13, 2021

Date Posted: March 2, 2022

Recall Number: Z-0668-2022

Event ID: 89495

Reason for Recall:

Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery

Status: Terminated

Product Quantity: 68 units

Code Information:

Model Number CDSLM45 Lot Number 2107292022 Exp Date:7/31/2024 UDI: (01)00813954020273(17)240731(10)2107292022

Distribution Pattern:

DuraMatrix-Onlay distributed US Nationwide in the states of FL, IN, Puerto Rico, and the countries of Canada, Chile, and Colombia. RESODURA matrix onlay distributed in Germany.

Voluntary or Mandated:

Voluntary: Firm initiated