Medical DeviceOct 5, 2022
Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was distributed recall — FDA Z-1777-2022
The packaging may not be sealed, which could compromise sterility.
Class IIFDA: OngoingCollagen Matrix Inc.
Recall history in this database
Classification mix: Class II: 10.
Medical DeviceMar 2, 2022
Collagen Matrix DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches recall — FDA Z-0668-2022
Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery
Class IIFDA: TerminatedCollagen Matrix, Inc.
Medical DeviceMar 2, 2022
Collagen Matrix RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for recall — FDA Z-0669-2022
Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery
Class IIFDA: TerminatedCollagen Matrix, Inc.
Medical DeviceFeb 5, 2020
Collagen Matrix GIBSON Healthcare Membrane Extended, 20mm x 30mm, Reference Number 5303-324 recall — FDA Z-0911-2020
The products may have been packaged with an incorrect Instructions for Use.
Class IIFDA: TerminatedCollagen Matrix Inc.
Medical DeviceFeb 5, 2020
Collagen Matrix GIBSON Healthcare Membrane Extended, 15mm x 20mm, Reference Number 5303-306 recall — FDA Z-0910-2020
The products may have been packaged with an incorrect Instructions for Use.
Class IIFDA: TerminatedCollagen Matrix Inc.
Medical DeviceFeb 5, 2020
Collagen Matrix GIBSON Healthcare Membrane 6-9, 15mm x 20mm, Reference Number 5303-226 recall — FDA Z-0907-2020
The products may have been packaged with an incorrect Instructions for Use.
Class IIFDA: TerminatedCollagen Matrix Inc.
Medical DeviceFeb 5, 2020
Collagen Matrix GIBSON Healthcare Membrane 6-9, 30mm x 40mm, Reference Number 5303-299 recall — FDA Z-0909-2020
The products may have been packaged with an incorrect Instructions for Use.
Class IIFDA: TerminatedCollagen Matrix Inc.
Medical DeviceFeb 5, 2020
Collagen Matrix GIBSON Healthcare Membrane 6-9, 20mm x 30mm, Reference Number 5303-235 recall — FDA Z-0908-2020
The products may have been packaged with an incorrect Instructions for Use.
Class IIFDA: TerminatedCollagen Matrix Inc.
Medical DeviceFeb 5, 2020
Collagen Matrix GIBSON Healthcare Membrane Extended, 30mm x 40mm, Reference Number 5303-342 recall — FDA Z-0912-2020
The products may have been packaged with an incorrect Instructions for Use.
Class IIFDA: TerminatedCollagen Matrix Inc.
Medical DeviceMay 29, 2019
Collagen Matrix Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model) recall — FDA Z-1389-2019
Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box
Class IIFDA: TerminatedCollagen Matrix, Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Collagen Matrix, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.