FDA recall Z-0669-2022

Collagen Matrix, Inc. · Class II · device

Product

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

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

Distribution

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.

Key facts

Status: Terminated
Initiation date: 2021-12-13
Report date: 2022-03-02
Termination date: 2024-09-18
Voluntary/Mandated: Voluntary: Firm initiated
Location: Allendale, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0669-2022