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Collagen Matrix Recalls
15 recalls on record · March 23, 2016 to October 5, 2022 · Medical Devices
Recalls by year
16
18
19
20
22
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 5, 2022Medical DevicesFDA
Collagen Matrix Inc recalls Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was distributed under the following brand nam
Hazard: The packaging may not be sealed, which could compromise sterility.
March 2, 2022Medical DevicesFDA
Collagen Matrix, Inc. recalls RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter. REF: DUMO10125
Hazard: Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery
March 2, 2022Medical DevicesFDA
Collagen Matrix, Inc. recalls DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45
Hazard: Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery
February 5, 2020Medical DevicesFDA
Collagen Matrix Inc recalls GIBSON Healthcare Membrane Extended, 30mm x 40mm, Reference Number 5303-342 - Product Usage: Indicated for use in oral s
Hazard: The products may have been packaged with an incorrect Instructions for Use.
February 5, 2020Medical DevicesFDA
Collagen Matrix Inc recalls GIBSON Healthcare Membrane Extended, 20mm x 30mm, Reference Number 5303-324 - Product Usage: Indicated for use in oral s
Hazard: The products may have been packaged with an incorrect Instructions for Use.
February 5, 2020Medical DevicesFDA
Collagen Matrix Inc recalls GIBSON Healthcare Membrane Extended, 15mm x 20mm, Reference Number 5303-306 - - Product Usage: Indicated for use in oral
Hazard: The products may have been packaged with an incorrect Instructions for Use.
February 5, 2020Medical DevicesFDA
Collagen Matrix Inc recalls GIBSON Healthcare Membrane 6-9, 30mm x 40mm, Reference Number 5303-299 - Product Usage: Indicated for use in oral surgic
Hazard: The products may have been packaged with an incorrect Instructions for Use.
February 5, 2020Medical DevicesFDA
Collagen Matrix Inc recalls GIBSON Healthcare Membrane 6-9, 20mm x 30mm, Reference Number 5303-235 - Product Usage: Indicated for use in oral surgic
Hazard: The products may have been packaged with an incorrect Instructions for Use.
February 5, 2020Medical DevicesFDA
Collagen Matrix Inc recalls GIBSON Healthcare Membrane 6-9, 15mm x 20mm, Reference Number 5303-226 - Product Usage: Indicated for use in oral surgic
Hazard: The products may have been packaged with an incorrect Instructions for Use.
May 29, 2019Medical DevicesFDA
Collagen Matrix, Inc. recalls Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520 - Product Usage: Neomem is a bioreso
Hazard: Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box
January 23, 2019Medical DevicesFDA
Collagen Matrix Inc recalls Porcine Anorganic Bone Mineral 4.0cc
Hazard: There is a possibility that the product labeled as 4.0cc volume may only contain 2.0cc volume and is therefore mislabeled.
November 21, 2018Medical DevicesFDA
Collagen Matrix, Inc. recalls BioMend Extend, REF# 0142Z, Synthetic bone grafting material.
Hazard: There is a possibility that the product was packaged in the wrong box. Specifically, the product may have been placed inside a BioMend box instead of a BioMend Extend box. The only difference between the two boxes is the product trade name. The label placed on the box and on the product packaged inside the box is correct. The Instructions for Use inside the box are correct.
March 23, 2016Medical DevicesFDA
Collagen Matrix Inc recalls ZCORE Porcine Xenograft Particulate in Syringe Product Intended for use in dental surgery such as: -Augmentation or
Hazard: The distributor, Osteogenics Biomedical, notified the firm that the syringes were not working properly and the syringes were being held in quarantine.
March 23, 2016Medical DevicesFDA
Collagen Matrix Inc recalls NuOss XC Sinus Reference No 509-3001 (BMCU17, size 17 mm diameter x 10 mm height) Reference No 509-3002 (BMCU22, size
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.
March 23, 2016Medical DevicesFDA
Collagen Matrix Inc recalls NuOSS Cancellous Intended for use in dental surgery.
Hazard: On 8/25/2015, Collagen Matrix, Inc discovered that one of the 171 units of NuOss Cancellous product shipped to a distributor may have included an incorrect size.