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Collagen Matrix, Inc. recalls DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45
Recalled March 2, 2022 · FDA recall Z-0668-2022 · Collagen Matrix
Hazard
Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery · FDA Class II
Units
68 units
Sold at
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.
Description
Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery
Product
DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45
Manufacturer(s)
Collagen Matrix, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →