The Recall Desk

Manufacturer

Medtronic Sofamor Danek USA, Inc

85 recalls in our database name Medtronic Sofamor Danek USA, Inc as the manufacturing or recalling firm.

What the numbers show

Total
85
Critical
0
Severe
1
Most recent
2025-12-03

Of the 85 recalls from Medtronic Sofamor Danek USA, Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (1%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

76–85 of 85

  • HighFDA (Devices)·Z-1589-2013·2013-07-03

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1591-2013·2013-07-03

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1590-2013·2013-07-03

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1592-2013·2013-07-03

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1595-2013·2013-07-03

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1593-2013·2013-07-03

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1594-2013·2013-07-03

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0038-2013·2012-10-17

    Medtronic Premier Anterior Cervical Plate Screw Block Recall

    Medtronic is recalling 247 units of the Premier Anterior Cervical Plate System Screw Block because gauge lines may be misaligned, potentially causing screws to be measured as 1 mm shorter than their actual length.

    Product
    PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0036-2013·2012-10-17

    Medtronic Atlantis Anterior Cervical Plate Screw Module Recalled for Measurement Error

    Medtronic is recalling the Atlantis Anterior Cervical Plate System Variable Angle Screw Module because gauge lines may be misaligned, leading to inaccurate screw length measurements.

    Product
    ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring func
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0037-2013·2012-10-17

    Medtronic Atlantis Anterior Cervical Plate Screw Module Recall

    Medtronic is recalling Atlantis Anterior Cervical Plate System screw modules because gauge lines may be misplaced, leading to inaccurate screw length measurements.

    Product
    ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring functio
    Category
    Medical Device
    Distribution
    Distributed nationwide