Collagen Matrix, Inc.

FDA Regulatory Profile

Summary

Total Recalls
15
510(k) Clearances
47
Inspections
6
Compliance Actions
2

Recent Recalls

NumberClassProductDate
Z-1777-2022Class IICollagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was distributed under theAugust 3, 2022
Z-0668-2022Class IIDuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDDecember 13, 2021
Z-0669-2022Class IIRESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura mattDecember 13, 2021
Z-0907-2020Class IIGIBSON Healthcare Membrane 6-9, 15mm x 20mm, Reference Number 5303-226 - Product Usage: Indicated foNovember 5, 2019
Z-0910-2020Class IIGIBSON Healthcare Membrane Extended, 15mm x 20mm, Reference Number 5303-306 - - Product Usage: IndicNovember 5, 2019
Z-0912-2020Class IIGIBSON Healthcare Membrane Extended, 30mm x 40mm, Reference Number 5303-342 - Product Usage: IndicatNovember 5, 2019
Z-0909-2020Class IIGIBSON Healthcare Membrane 6-9, 30mm x 40mm, Reference Number 5303-299 - Product Usage: Indicated foNovember 5, 2019
Z-0911-2020Class IIGIBSON Healthcare Membrane Extended, 20mm x 30mm, Reference Number 5303-324 - Product Usage: IndicatNovember 5, 2019
Z-0908-2020Class IIGIBSON Healthcare Membrane 6-9, 20mm x 30mm, Reference Number 5303-235 - Product Usage: Indicated foNovember 5, 2019
Z-1389-2019Class IINeomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520 - Product Usage:March 19, 2019
Z-0752-2019Class IIIPorcine Anorganic Bone Mineral 4.0ccOctober 30, 2018
Z-0414-2019Class IIIBioMend Extend, REF# 0142Z, Synthetic bone grafting material.August 16, 2018
Z-1173-2016Class IIIZCORE Porcine Xenograft Particulate in Syringe Product Intended for use in dental surgery such asNovember 17, 2015
Z-1096-2016Class IINuOSS Cancellous Intended for use in dental surgery.August 25, 2015
Z-1097-2016Class IINuOss XC Sinus Reference No 509-3001 (BMCU17, size 17 mm diameter x 10 mm height) Reference No 509May 13, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K251191Collagen Dura Regeneration Membrane - RepairNovember 18, 2025
K243071Bovine Dermis Collagen Dermal MatrixDecember 19, 2024
K242302RejuvaKnee™ Collagen Meniscus ImplantOctober 2, 2024
K233203Soft Tissue Augmentation Resorbable MatrixMay 1, 2024
K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixMarch 12, 2024
K231942Mineral Collagen Composite Bioactive Extra MoldableAugust 2, 2023
K221735Mineral Collagen Composite Bioactive MoldableDecember 20, 2022
K213341Fibrillar Collagen Wound DressingMay 31, 2022
K202183Porcine Mineral Collagen CompositeApril 2, 2021
K201859Porcine Mineral Collagen Composite MoldableSeptember 11, 2020
K182074Mineral Collagen Composite Bioactive MoldableMarch 21, 2019
K171008Anorganic Bone Mineral with Collagen in Delivery ApplicatorOctober 30, 2017
K170541Anorganic Bone Mineral in Delivery ApplicatorJuly 7, 2017
K170656Reinforced Flexible Collagen Nerve CuffJune 1, 2017
K162158Porcine Anorganic Bone Mineral in Delivery ApplicatorFebruary 9, 2017
K152600Collagen Dental Wound DressingsJune 23, 2016
K150825Collagen Dural Regeneration MatrixNovember 20, 2015
K141608COLLAGEN DURA MEMBRANEJanuary 16, 2015
K142496Collagen Dental Membrane - Conformable IIBPNovember 24, 2014
K141909COLLAGEN DENTAL MEMBRANE - CONFORMABLE PPNovember 5, 2014