Collagen Matrix, Inc. recalls RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural
Recalled Product
RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter. REF: DUMO10125
Hazard / Issue
Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: Lot Number 2107292022 Exp. Date: 7/31/2024 UDI: (01)00813954023267(17)240731(10)2107292022 (note: UDI edited 3/7/2022)
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