Home / Recalls / Collagen Matrix, Inc. / Z-0669-2022

Z-0669-2022 Class II Terminated

Recalled by Collagen Matrix, Inc. — Allendale, NJ

Recall Details

Product Type
Devices
Report Date
March 2, 2022
Initiation Date
December 13, 2021
Termination Date
September 18, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10 units

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

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.

Code Information

Lot Number 2107292022 Exp. Date: 7/31/2024 UDI: (01)00813954023267(17)240731(10)2107292022 (note: UDI edited 3/7/2022)

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  • Z-1777-2022 Class II — Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was d (August 3, 2022)
  • Z-0668-2022 Class II — DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm (December 13, 2021)
  • Z-0907-2020 Class II — GIBSON Healthcare Membrane 6-9, 15mm x 20mm, Reference Number 5303-226 - Product (November 5, 2019)
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  • Z-0911-2020 Class II — GIBSON Healthcare Membrane Extended, 20mm x 30mm, Reference Number 5303-324 - Pr (November 5, 2019)
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  • Z-1389-2019 Class II — Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1 (March 19, 2019)
  • Z-0752-2019 Class III — Porcine Anorganic Bone Mineral 4.0cc (October 30, 2018)