The Recall Desk

FDA (Devices) recall action 68331

Stryker Instruments Div. of Stryker Corporation recalled 32 products on 2014-06-18

The FDA (Devices) publishes a recall like this one as 32 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 32 pages.

Products
32
Announced
2014-06-18
Critical
0
Units
13,739

Why these products were recalled

There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

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.

26–32 of 32

  • ModerateFDA (Devices)··2014-06-18

    Stryker 1.3mm Wire Pass Drill Recalled for Missing Notches

    Stryker is recalling 176 sterile 1.3mm Wire Pass Drills because some units may have missing or partial notches.

    Product
    Stryker 1.3mm Wire Pass Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications incl
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-06-18

    Stryker Wire Pass Drill Recalled for Missing Notches

    Stryker is recalling 246 sterile 1.5mm Wire Pass Drills because some units may have missing or partial notches, which could affect their use with Elite Attachments.

    Product
    Stryker 1.5mm Wire Pass Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications incl
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-06-18

    Stryker 3.0mm Round Fluted Bur Recalled for Missing Notches

    Stryker is recalling 285 sterile 3.0mm Round Fluted Bur Aggressive devices due to missing or partial notches. The defect may affect the device's compatibility with Elite Attachments.

    Product
    Stryker 3.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical appli
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-06-18

    Stryker 4.0mm Round Fluted Bur Recall Due to Missing Notches

    Stryker is recalling 281 units of 4.0mm Round Fluted Burs because some may have missing or partial notches, which could affect their use with Elite Attachments.

    Product
    Stryker 4.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications incl
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-06-18

    Stryker Round Fluted Bur Recalled for Missing Notches

    Stryker is recalling 72 sterile 1.0mm Round Fluted Burs because some units may have missing or partial notches, which could affect their use with Elite Attachments.

    Product
    Stryker 1.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications in
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-06-18

    Stryker Neuro Drill Accessories Recalled for Missing Notches

    Stryker is recalling 188 sterile neuro drill accessories because some units have missing or partial notches, which may affect their use with Elite attachments.

    Product
    Stryker 4.0mm x 5.1mm Neuro Drill Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical ap
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-06-18

    Stryker Lindemann Drill Short Recalled for Missing Notches

    Stryker is recalling 12 Lindemann Drill Short units because some cutting accessories may have missing or partial notches.

    Product
    Lindemann Drill Short, 1.6mm Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications inclu
    Category
    Distribution
    0 states