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

Reason: Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery

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.