Collagen Matrix Inc: The products may have been packaged with an incorrect Instructions for Use.

Agency Publication Date: January 29, 2020

Affected Products

Product: GIBSON Healthcare Membrane 6-9, 15mm x 20mm, Reference Number 5303-226 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodo

UDI: (01)00366975013248(17)200630; Lot Number PDMU18F1, PDMU19A1

Lot Numbers:

Number

Product: GIBSON Healthcare Membrane 6-9, 20mm x 30mm, Reference Number 5303-235 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodo

UDI: (01)00366975013255(17)200630; Lot Number PDMU18F1

Lot Numbers:

Number

Product: GIBSON Healthcare Membrane 6-9, 30mm x 40mm, Reference Number 5303-299 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodo

UDI: (01)00366975013255(17)210531; Lot Number PDMU19C1

Lot Numbers:

Number

Product: GIBSON Healthcare Membrane Extended, 15mm x 20mm, Reference Number 5303-306 - - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in

UDI: (01)00366975013279(17)200630; Lot Number EPDMU18H1

Lot Numbers:

Number

Product: GIBSON Healthcare Membrane Extended, 20mm x 30mm, Reference Number 5303-324 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in pe

UDI: (01)00366975013286(17)200630; Lot Number EPDMU18H1

Lot Numbers:

Number

Product: GIBSON Healthcare Membrane Extended, 30mm x 40mm, Reference Number 5303-342 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in pe

UDI: (01)00366975013293(17)200630; Lot Number EPDMU18H1

Lot Numbers:

Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84334

Status: Resolved

Manufacturer: Collagen Matrix Inc

Manufactured In: United States

Units Affected: 6 products (192 total)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

UDI: (01)00366975013248(17)200630; Lot Number PDMU18F1, PDMU19A1

Lot Numbers:

Number

UDI: (01)00366975013255(17)200630; Lot Number PDMU18F1

Lot Numbers:

Number

UDI: (01)00366975013255(17)210531; Lot Number PDMU19C1

Lot Numbers:

Number

UDI: (01)00366975013279(17)200630; Lot Number EPDMU18H1

Lot Numbers:

Number

UDI: (01)00366975013286(17)200630; Lot Number EPDMU18H1

Lot Numbers:

Number

UDI: (01)00366975013293(17)200630; Lot Number EPDMU18H1

Lot Numbers:

Number