Collagen Matrix, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0669-2022)

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:

RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter. REF: DUMO10125

Product Classification:

Class II

Date Initiated: December 13, 2021

Date Posted: March 2, 2022

Recall Number: Z-0669-2022

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: 10 units

Code Information:

Lot Number 2107292022 Exp. Date: 7/31/2024 UDI: (01)00813954023267(17)240731(10)2107292022 (note: UDI edited 3/7/2022)

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