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.

1–25 of 32

ModerateFDA (Devices)··2014-06-18
Stryker Recalls Zyphr Elite Round Fluted Bur Due to Missing Notches
Stryker is recalling four sterile Zyphr Elite Round Fluted Burs because some units may have missing or partial notches, potentially affecting their use with Elite Attachments.
Product
Stryker 2.0mm Zyphr Elite 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…
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ModerateFDA (Devices)··2014-06-18
Stryker Neuro Drill Accessories Recalled for Missing Notches
Stryker is recalling 41 sterile neuro drill accessories due to missing or partial notches that may affect compatibility with Elite attachments.
Product
Stryker 2.5mm x 3.6mm 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…
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ModerateFDA (Devices)··2014-06-18
Stryker 5.5mm Round Fluted Bur Recall Due to Missing Notches
Stryker is recalling 99 sterile 5.5mm Round Fluted Bur Soft Touch devices because some units may have missing or partial notches.
Product
Stryker 5.5mm Round Fluted Bur 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…
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ModerateFDA (Devices)··2014-06-18
Stryker Recalls Zyphr Elite Round Fluted Bur Due to Missing Notches
Stryker is recalling 107 sterile Zyphr Elite Round Fluted Burs because some units may have missing or partial notches, which could affect their use with Elite Attachments.
Product
Stryker 6.0mm Zyphr Elite 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…
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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…
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ModerateFDA (Devices)··2014-06-18
Stryker Round Fluted Bur Recall Due to Missing Notches
Stryker is recalling 301 sterile 6.0mm Round Fluted Bur Aggressive devices because some units have missing or partial notches.
Product
Stryker 6.0mm 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…
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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…
Category
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ModerateFDA (Devices)··2014-06-18
Stryker 5.0mm Acorn Bur Recalled for Missing Notches
Stryker is recalling 71 units of 5.0mm Acorn Bur sterile cutting accessories due to missing or partial notches.
Product
Stryker 5.0mm Acorn 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 including…
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ModerateFDA (Devices)··2014-06-18
Stryker Zyphr Elite Round Fluted Bur Recall for Missing Notches
Stryker is recalling 39 sterile Zyphr Elite Round Fluted Burs because some units may have missing or partial notches, which could affect their use with Elite Attachments.
Product
Stryker 3.5mm Zyphr Elite 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…
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ModerateFDA (Devices)··2014-06-18
Stryker 5.0mm Round Fluted Bur Recall Due to Missing Notches
Stryker is recalling 1,537 sterile 5.0mm Round Fluted Bur Aggressive devices because some units have missing, partial, or no notches.
Product
Stryker 5.0mm 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…
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…
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ModerateFDA (Devices)··2014-06-18
Stryker 5.0mm Barrel Bur Recall Due to Missing Notches
Stryker is recalling 15 units of 5.0mm Barrel Bur Sterile because some units may have missing or partial notches.
Product
Stryker 5.0mm Barrel Bur Sterile
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ModerateFDA (Devices)··2014-06-18
Stryker 5.5mm Round Fluted Bur Recall Due to Missing Notches
Stryker is recalling 84 sterile 5.5mm Round Fluted Bur Aggressive devices because some units have missing or partial notches.
Product
Stryker 5.5mm 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…
Category
Distribution
0 states
ModerateFDA (Devices)··2014-06-18
Stryker 2.0mm Round Fluted Bur Recalled for Missing Notches
Stryker is recalling 252 sterile 2.0mm Round Fluted Burs because some units have missing or partial notches, which may affect their use with Elite Attachments.
Product
Stryker 2.0mm 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…
Category
Distribution
0 states
ModerateFDA (Devices)··2014-06-18
Stryker Round Fluted Bur Recall Due to Missing Notches
Stryker is recalling 609 sterile 3.0mm Round Fluted Burs because some units have missing or partial notches, which may affect their use with Elite Attachments.
Product
Stryker 3.0mm Round Fluted Bur 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…
Category
Distribution
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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…
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ModerateFDA (Devices)··2014-06-18
Stryker Neuro Drill Recall Due to Missing Notches on Cutting Accessories
Stryker is recalling 497 sterile neuro drills because some cutting accessories may have missing or partial notches, which could affect their use with Elite attachments.
Product
Stryker 3.0mm x 3.8mm Neuro 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…
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ModerateFDA (Devices)··2014-06-18
Stryker 6.0mm Egg Bur Recall Due to Missing Notches
Stryker is recalling 65 units of 6.0mm Egg Bur sterile surgical instruments because some units have missing or partial notches.
Product
Stryker 6.0mm Egg 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 including…
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ModerateFDA (Devices)··2014-06-18
Stryker 6.0mm Acorn Bur Recalled for Missing Notches
Stryker is recalling 59 sterile 6.0mm Acorn Burs because some units have missing or partial notches, which may affect their use with Elite Attachments.
Product
Stryker 6.0mm Acorn 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 including…
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…
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…
Category
Distribution
0 states
ModerateFDA (Devices)··2014-06-18
Stryker 6.0mm Round Fluted Bur Recalled for Missing Notches
Stryker is recalling 256 units of 6.0mm Round Fluted Bur due to missing or partial notches that may affect compatibility with Elite Attachments.
Product
Stryker 6.0mm 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…
Category
Distribution
0 states
ModerateFDA (Devices)··2014-06-18
Stryker Neuro Drill Soft Touch Recalled for Missing Notches
Stryker is recalling 802 sterile neuro drill accessories due to missing or partial notches that may affect compatibility with Elite attachments.
Product
Stryker 3.0mm x 3.8mm 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…
Category
Distribution
0 states
ModerateFDA (Devices)··2014-06-18
Stryker Precision Neuro Drill Recall Due to Missing Notches
Stryker is recalling 6,481 Precision Neuro Drills because some cutting accessories may have missing or partial notches, which could affect their use with Elite Attachments.
Product
Stryker 3.0mm x 3.8mm Precision Neuro 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…
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ModerateFDA (Devices)··2014-06-18
Stryker Elite Bur Recall Due to Missing Notches
Stryker is recalling 2.0mm Tapered Round Elite Burs because some units have missing or partial notches. The devices are used for cutting bone during surgery.
Product
Stryker 2.0mm Tapered Round Elite 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…
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