The Recall Desk

Manufacturer

Medtronic Sofamor Danek Usa, Inc - Dallas Distribution

3 recalls in our database name Medtronic Sofamor Danek Usa, Inc - Dallas Distribution as the manufacturing or recalling firm.

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2016-07-06

Of the 3 recalls from Medtronic Sofamor Danek Usa, Inc - Dallas Distribution we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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.

1–3 of 3

  • HighFDA (Devices)·Z-2085-2016·2016-07-06

    Medtronic Recalls Sagittal Saw Devices Due to Potential Fluid Leakage

    Medtronic is recalling 368 Sagittal Saw devices because testing identified a potential for fluid leakage into the motor during use.

    Product
    Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Saw Saggital, Finger Catalog Number: ES310; Saw Saggital, Finger Refurbished Catalog Number: ES310-R; Used to dissect bone in surgical applications.
    Category
    Medical Device
    Distribution
    20 states
  • ModerateFDA (Devices)·Z-1602-2016·2016-05-11

    Medtronic Midas Rex Dissecting Tools Recalled for Labeling Errors

    Medtronic is recalling 81 Midas Rex Dissecting Tools due to incorrect color coding and attachment references on the labeling.

    Product
    Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0321-2016·2015-12-02

    Medtronic Sofamor Danek Recalls Midas Rex Legend Wire Pass Tools

    Medtronic Sofamor Danek is recalling 9 Midas Rex Legend wire pass tools because the wire pass hole is missing. The tools were distributed in California, New York, Texas, and Belgium.

    Product
    Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill holes.
    Category
    Medical Device
    Distribution
    3 states