RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter. REF: DUMO10125
Check against the official notice below — it lists the full affected range.
Collagen Matrix, Inc. is recalling RESODURA matrix onlay devices (10.0 cm x 12.5 cm) used as dural substitutes to repair the dura mater. The outer packaging on these devices is not properly sealed, which compromises sterility and creates a potential risk of patient infection that could require revision surgery. The recall affects 10 units from Lot Number 2107292022 with an expiration date of July 31, 2024, distributed across Florida, Indiana, Puerto Rico, Canada, Chile, Colombia, and Germany.
The source document does not specify a remedy or instructions for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery
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. Quantity: 10 units Lot/code info: Lot Number 2107292022 Exp. Date: 7/31/2024 UDI: (01)00813954023267(17)240731(10)2107292022 (note: UDI edited 3/7/2022)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.