Collagen Matrix, Inc.
FDA Regulatory Profile
Collagen Matrix, Inc. appears in FDA public data with 15 recalls, 47 510(k) clearances, 6 FDA inspections, and 2 compliance actions on record. Its most recent recall (Z-1777-2022, Class II) was initiated on August 3, 2022. Its most recent 510(k) clearance was granted on November 18, 2025.
Summary
- Total Recalls
- 15
- 510(k) Clearances
- 47
- Inspections
- 6
- Compliance Actions
- 2
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1777-2022 | Class II | Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was distributed under the | August 3, 2022 |
| Z-0668-2022 | Class II | DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CD | December 13, 2021 |
| Z-0669-2022 | Class II | RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matt | December 13, 2021 |
| Z-0907-2020 | Class II | GIBSON Healthcare Membrane 6-9, 15mm x 20mm, Reference Number 5303-226 - Product Usage: Indicated fo | November 5, 2019 |
| Z-0910-2020 | Class II | GIBSON Healthcare Membrane Extended, 15mm x 20mm, Reference Number 5303-306 - - Product Usage: Indic | November 5, 2019 |
| Z-0912-2020 | Class II | GIBSON Healthcare Membrane Extended, 30mm x 40mm, Reference Number 5303-342 - Product Usage: Indicat | November 5, 2019 |
| Z-0909-2020 | Class II | GIBSON Healthcare Membrane 6-9, 30mm x 40mm, Reference Number 5303-299 - Product Usage: Indicated fo | November 5, 2019 |
| Z-0911-2020 | Class II | GIBSON Healthcare Membrane Extended, 20mm x 30mm, Reference Number 5303-324 - Product Usage: Indicat | November 5, 2019 |
| Z-0908-2020 | Class II | GIBSON Healthcare Membrane 6-9, 20mm x 30mm, Reference Number 5303-235 - Product Usage: Indicated fo | November 5, 2019 |
| Z-1389-2019 | Class II | Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520 - Product Usage: | March 19, 2019 |
| Z-0752-2019 | Class III | Porcine Anorganic Bone Mineral 4.0cc | October 30, 2018 |
| Z-0414-2019 | Class III | BioMend Extend, REF# 0142Z, Synthetic bone grafting material. | August 16, 2018 |
| Z-1173-2016 | Class III | ZCORE Porcine Xenograft Particulate in Syringe Product Intended for use in dental surgery such as | November 17, 2015 |
| Z-1096-2016 | Class II | NuOSS Cancellous Intended for use in dental surgery. | August 25, 2015 |
| Z-1097-2016 | Class II | NuOss XC Sinus Reference No 509-3001 (BMCU17, size 17 mm diameter x 10 mm height) Reference No 509 | May 13, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251191 | Collagen Dura Regeneration Membrane - Repair | November 18, 2025 |
| K243071 | Bovine Dermis Collagen Dermal Matrix | December 19, 2024 |
| K242302 | RejuvaKnee Collagen Meniscus Implant | October 2, 2024 |
| K233203 | Soft Tissue Augmentation Resorbable Matrix | May 1, 2024 |
| K240424 | Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix | March 12, 2024 |
| K231942 | Mineral Collagen Composite Bioactive Extra Moldable | August 2, 2023 |
| K221735 | Mineral Collagen Composite Bioactive Moldable | December 20, 2022 |
| K213341 | Fibrillar Collagen Wound Dressing | May 31, 2022 |
| K202183 | Porcine Mineral Collagen Composite | April 2, 2021 |
| K201859 | Porcine Mineral Collagen Composite Moldable | September 11, 2020 |
| K182074 | Mineral Collagen Composite Bioactive Moldable | March 21, 2019 |
| K171008 | Anorganic Bone Mineral with Collagen in Delivery Applicator | October 30, 2017 |
| K170541 | Anorganic Bone Mineral in Delivery Applicator | July 7, 2017 |
| K170656 | Reinforced Flexible Collagen Nerve Cuff | June 1, 2017 |
| K162158 | Porcine Anorganic Bone Mineral in Delivery Applicator | February 9, 2017 |
| K152600 | Collagen Dental Wound Dressings | June 23, 2016 |
| K150825 | Collagen Dural Regeneration Matrix | November 20, 2015 |
| K141608 | COLLAGEN DURA MEMBRANE | January 16, 2015 |
| K142496 | Collagen Dental Membrane - Conformable IIBP | November 24, 2014 |
| K141909 | COLLAGEN DENTAL MEMBRANE - CONFORMABLE PP | November 5, 2014 |