RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura m...
FDA Recall #Z-0669-2022 — Class II — December 13, 2021
Product Description
RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter. REF: DUMO10125
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
Recalling Firm
Collagen Matrix, Inc. — Allendale, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
10 units
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.
Code Information
Lot Number 2107292022 Exp. Date: 7/31/2024 UDI: (01)00813954023267(17)240731(10)2107292022 (note: UDI edited 3/7/2022)
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated