Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches Recalled by Collagen Matrix, Inc. Due to Outer packaging (outer pouch) is not sealed compromising...

Date: December 13, 2021
Company: Collagen Matrix, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Collagen Matrix, Inc. directly.

Affected Products

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

Quantity: 68 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Collagen Matrix, Inc.

Collagen Matrix, Inc. has 4 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report