FDA-Device2022-03-02Class II
DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45
Collagen Matrix, Inc.
Hazard
Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery
Sold states
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.
Affected count
68 units
Manufactured in
110 Commerce Dr, Allendale, NJ, United States
Products
DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0668-2022Don't want to check this manually?
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