FDAMay 13, 2013device
NuOss XC Sinus Reference No 509-3001 (BMCU17, size 17 mm diameter x 10 mm height) Reference No 509-3002 (BMCU22, size 22 mm diameter x 12 m height) Manufacturer:- Collagen Matrix, Distributor:- ACE Surgical Supply Co, Inc, Intended use for dental surgery such as -augmentation or reconstructive tr...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
During the 36 month real time shelf life testing of NuOss XC Sinus (BMCU-Umbrella) to verify the 3 year shelf life designated for the device, 3 of 13 products did not pass the recovery test, which requires that the compressed product fully expand within 1 minute of hydration time.
What to do
FDA enforcement status: Terminated
Brands named
collagen matrixcollagen
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
- FDARESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter. REF: DUMO101252021-12-13
- FDADuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM452021-12-13
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