The Recall Desk

FDA (Devices) recall action 77894

Medtronic Navigation, Inc. recalled 5 products on 2017-09-27

The FDA (Devices) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2017-09-27
Critical
0
Units
10,255

Why these products were recalled

Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening once attached to a patient's spinous process or leaving a component behind in the patient's body following breakage.

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

1–5 of 5

  • SevereFDA (Devices)··2017-09-27

    Medtronic Spine Referencing Instrumentation Recalled for Potential Breakage

    Medtronic Navigation is recalling Spine Referencing Instrumentation sets due to a risk that clamps may break during use, potentially leaving components in the patient's body.

    Product
    Spine Referencing Instrumentation, Set, Contains Spinous Process Clamps, Short and Tall When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for…
    Category
    Distribution
    44 states
  • SevereFDA (Devices)··2017-09-27

    Medtronic Spine Referencing Instrumentation Recalled for Potential Damage

    Medtronic Navigation is recalling Spine Referencing Instrumentation, Double Spinous Process Clamp, Tall units due to a risk of component breakage or damage during use.

    Product
    Spine Referencing Instrumentation, Double Spinous Process Clamp, Tall When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the…
    Category
    Distribution
    44 states
  • SevereFDA (Devices)··2017-09-27

    Medtronic Spine Referencing Clamp Recall for Potential Breakage

    Medtronic is recalling Spine Referencing Instrumentation clamps due to a risk of breakage that could leave components in the patient's body.

    Product
    Spine Referencing Instrumentation, Spinous Process Clamp, Tall When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the…
    Category
    Distribution
    44 states
  • SevereFDA (Devices)··2017-09-27

    Medtronic Spine Referencing Instrumentation Recalled for Potential Damage

    Medtronic is recalling Spine Referencing Instrumentation because the clamps may be damaged if opened beyond limits, potentially leaving components in the patient.

    Product
    Spine Referencing Instrumentation, Spinous Process Clamp, Short When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the…
    Category
    Distribution
    44 states
  • SevereFDA (Devices)··2017-09-27

    Medtronic Spine Referencing Instrumentation Recalled for Potential Breakage

    Medtronic is recalling Spine Referencing Instrumentation, Double Spinous Process Clamp, Short units because they may break during use, potentially leaving components in the patient's body.

    Product
    Spine Referencing Instrumentation, Double Spinous Process Clamp, Short When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of…
    Category
    Distribution
    44 states