Home / Recalls / Collagen Matrix, Inc. / Z-0668-2022

Z-0668-2022 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
68 units

Product Description

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

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

Model Number CDSLM45 Lot Number 2107292022 Exp Date:7/31/2024 UDI: (01)00813954020273(17)240731(10)2107292022

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  • Z-0669-2022 Class II — RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the (December 13, 2021)
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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)