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Collagen Matrix, Inc. Recall 89495

Description: DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45

Collagen Matrix, Inc. Recall 89495 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0668-2022
Event ID89495
Event DescriptionDuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45
Product TypeDevices
DistributionDuraMatrix-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.
Quantity68 units
Recall ReasonOuter packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery
Device Classification20220302
Device Code InfoModel Number CDSLM45 Lot Number 2107292022 Exp Date:7/31/2024 UDI: (01)00813954020273(17)240731(10)2107292022
Center Classification Date20220224
Recall Initiation Date20211213
Recalling FirmCollagen Matrix, Inc.
Initial Notification Letter
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