DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45
Check against the official notice below — it lists the full affected range.
Collagen Matrix, Inc. has recalled 68 units of DuraMatrix-Onlay Collagen Dura Substitute Membrane (4 inches x 5 inches, model number CDSLM45, lot number 2107292022, expiration date 7/31/2024) distributed nationwide in Florida, Indiana, Puerto Rico, Canada, Chile, and Colombia, as well as RESODURA matrix onlay distributed in Germany. The outer packaging pouch is not sealed, which compromises sterility and creates a potential risk of patient infection that could require revision surgery.
The recall notice does not specify a remedy or instructions for what affected consumers should do.
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: 68 units Lot/code info: Model Number CDSLM45 Lot Number 2107292022 Exp Date:7/31/2024 UDI: (01)00813954020273(17)240731(10)2107292022
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.