FDADecember 13, 2021device
RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter. REF: DUMO10125
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery
What to do
FDA enforcement status: Terminated
Brands named
collagen matrixcollagen
UPCs
00813954023267
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCJohnson Health Tech Expands Recall to Include Matrix Retail and Vision Treadmills Due to Fire Hazard2026-01-22
- CPSCJohnson Health Tech North America Recalls Matrix-Brand Training Cycles Due to Fall Hazard2025-01-30
- CPSCJohnson Health Tech North America Expands Recall of Matrix T1 and T3 Commercial Treadmills Due to Fire Hazard (Recall Alert)2024-04-11
- FDACollagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was distributed under the following brand names: 1) Cytoplast RTMTAPE, 25mm x 75mm 2) GIBSON Healthcare, 25mm x 75mm 3) MaxxTape, 2.5cm x 7.5cm x 0.1cm 4) NEOTAPE, 25mm x 75mm 5) Karl Schumacher TAPE, 2.5cm x 7.5cm x 1mm2022-08-03
- CPSCJohnson Health Tech Recalls Matrix T1 and T3 Commercial Treadmills Due to Fire Hazard (Recall Alert)2022-01-28
- FDAMatrix Clinical Solution At-Home COVID-19 Test2022-01-24
- FDADuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM452021-12-13
- FDAPuraSinus Absorbable Nasal Hemostat, Part Numbers 651-0062019-12-02
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