The Recall Desk

FDA (Devices) recall action 84334

Collagen Matrix Inc recalled 6 products on 2020-02-05

The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.

Products
6
Announced
2020-02-05
Critical
0
Units
1,152

Why these products were recalled

The products may have been packaged with an incorrect Instructions for Use.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–6 of 6

  • ModerateFDA (Devices)··2020-02-05

    GIBSON Healthcare Membrane Recalled for Incorrect Instructions for Use

    Collagen Matrix Inc is recalling GIBSON Healthcare Membrane 6-9 units because they may have been packaged with incorrect Instructions for Use.

    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 rid
    Category
    Distribution
    20 states
  • ModerateFDA (Devices)··2020-02-05

    Collagen Matrix Recalls GIBSON Membrane Due to Incorrect Instructions

    Collagen Matrix Inc is recalling 192 units of GIBSON Healthcare Membrane 6-9 because they may have been packaged with incorrect Instructions for Use.

    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 rid
    Category
    Distribution
    20 states
  • ModerateFDA (Devices)··2020-02-05

    Collagen Matrix Recalls GIBSON Membrane Due to Incorrect Instructions

    Collagen Matrix Inc is recalling 192 units of GIBSON Healthcare Membrane Extended because they may have been packaged with incorrect Instructions for Use.

    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; localize
    Category
    Distribution
    20 states
  • ModerateFDA (Devices)··2020-02-05

    Collagen Matrix Recalls GIBSON Membrane Due to Incorrect Instructions

    Collagen Matrix Inc is recalling 192 units of GIBSON Healthcare Membrane Extended because they may have been packaged with incorrect Instructions for Use.

    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; locali
    Category
    Distribution
    20 states
  • ModerateFDA (Devices)··2020-02-05

    Collagen Matrix Recalls GIBSON Membrane Due to Incorrect Instructions

    Collagen Matrix Inc is recalling 192 units of GIBSON Healthcare Membrane 6-9 because they may have been packaged with incorrect Instructions for Use.

    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 rid
    Category
    Distribution
    20 states
  • ModerateFDA (Devices)··2020-02-05

    GIBSON Healthcare Membrane Extended Recalled for Incorrect Instructions for Use

    Collagen Matrix Inc is recalling 192 units of GIBSON Healthcare Membrane Extended because they may have been packaged with incorrect Instructions for Use.

    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; localize
    Category
    Distribution
    20 states