The Recall Desk

FDA (Devices) recall action 65297

Medtronic Sofamor Danek USA Inc recalled 7 products on 2013-07-03

The FDA (Devices) publishes a recall like this one as 7 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 7 pages.

Products
7
Announced
2013-07-03
Critical
0
Units
57,508

Why these products were recalled

Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.

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

1–7 of 7

  • HighFDA (Devices)··2013-07-03

    Medtronic Recalls INFUSE Bone Graft Kits Due to Endotoxin Levels

    Medtronic is recalling INFUSE Bone Graft kits because they contain a collagen sponge with possible elevated endotoxin levels.

    Product
    INFUSE(R) Bone Graft, LARGE II KIT, REF 7510800AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2013-07-03

    Medtronic Recalls INFUSE Bone Graft Kits Due to Endotoxin Levels

    Medtronic is recalling INFUSE Bone Graft kits because they contain a collagen sponge with possible elevated endotoxin levels.

    Product
    INFUSE(R) Bone Graft,LARGE II KIT, REF 7510800, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2013-07-03

    Medtronic Recalls INFUSE Bone Graft Kits Due to Endotoxin Concerns

    Medtronic is recalling INFUSE Bone Graft kits because they contain a collagen sponge with possible elevated endotoxin levels.

    Product
    INFUSE(R) Bone Graft, LARGE KIT, REF 7510600, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2013-07-03

    Medtronic Recalls INFUSE Bone Graft Kits Due to Endotoxin Levels

    Medtronic is recalling INFUSE Bone Graft kits because they contain a collagen sponge with possible elevated endotoxin levels.

    Product
    INFUSE(R) Bone Graft, SMALL KIT, REF 7510200AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2013-07-03

    Medtronic Recalls INFUSE Bone Graft Kits Due to Endotoxin Levels

    Medtronic is recalling 400 units of INFUSE Bone Graft kits because they contain a collagen sponge with possible elevated endotoxin levels.

    Product
    INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2013-07-03

    Medtronic Recalls INFUSE Bone Graft Kits Due to Endotoxin Levels

    Medtronic is recalling INFUSE Bone Graft kits because they contain a collagen sponge with possible elevated endotoxin levels.

    Product
    INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2013-07-03

    Medtronic Recalls INFUSE Bone Graft Kits Due to Endotoxin Levels

    Medtronic is recalling INFUSE Bone Graft kits because they contain a collagen sponge with possible elevated endotoxin levels.

    Product
    INFUSE(R) Bone Graft, SMALL KIT, REF 7510200, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
    Category
    Distribution
    1 state