The Recall Desk

Manufacturer

Stryker Instruments Div. of Stryker Corporation

161 recalls in our database name Stryker Instruments Div. of Stryker Corporation as the manufacturing or recalling firm.

What the numbers show

Total
161
Critical
4
Severe
11
Most recent
2022-07-27

Of the 161 recalls from Stryker Instruments Div. of Stryker Corporation we have scored against our rubric, 4 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 11 (7%) 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.

101–125 of 161

  • ModerateFDA (Devices)·Z-1759-2014·2014-06-18

    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 appli
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1754-2014·2014-06-18

    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 appli
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1753-2014·2014-06-18

    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 incl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1768-2014·2014-06-18

    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1766-2014·2014-06-18

    Stryker 5.0mm Egg Bur Recall Due to Missing Notches

    Stryker is recalling 144 units of 5.0mm Egg Bur sterile devices because some cutting accessories may have missing or partial notches.

    Product
    Stryker 5.0mm 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 ma
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1772-2014·2014-06-18

    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
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1773-2014·2014-06-18

    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
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1752-2014·2014-06-18

    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
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1750-2014·2014-06-18

    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
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1776-2014·2014-06-18

    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
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1771-2014·2014-06-18

    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
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1770-2014·2014-06-18

    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
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1755-2014·2014-06-18

    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 appli
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1774-2014·2014-06-18

    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 ap
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1767-2014·2014-06-18

    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 ma
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1761-2014·2014-06-18

    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 applicati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1763-2014·2014-06-18

    Stryker Recalls Four Zyphr Elite Round Fluted Bur Units

    Stryker is recalling four sterile Zyphr Elite Round Fluted Bur units due to missing or partial notches that may affect compatibility with Elite attachments.

    Product
    Stryker 5.0mm 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 appl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1757-2014·2014-06-18

    Stryker 4.5mm Round Fluted Bur Recall for Missing Notches

    Stryker is recalling 62 units of 4.5mm Round Fluted Bur Aggressive Sterile devices due to missing or partial notches.

    Product
    Stryker 4.5mm 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 appli
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1775-2014·2014-06-18

    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 appl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1715-2014·2014-06-11

    Stryker NAV3i Platform Power Boxes Recalled for Missing Electrical Insulation

    Stryker is recalling 20 NAV3i Platform Power Boxes because they may lack electrical insulation on soldering joints, posing a shock hazard.

    Product
    The Stryker NAV3i Platform is a mobile cart platform consisting of the sub-components Stryker Nav3 Graphite Camera, SPC-3 Computer and IO-Tablet (touch screen) as well as the monitor, articulated arms and cart housing. This Navigation system is used in combination with surgical
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-1716-2014·2014-06-11

    Stryker NAV3i Platform Power Box Recalled for Missing Electrical Insulation

    Stryker is recalling 20 NAV3i Platform Power Boxes that may lack electrical insulation on soldering joints, posing a risk of electric shock.

    Product
    The NAV3i Platform Power Box supplies the electrical components with power (e.g. Stryker Nav3 Graphite Camera, SPC-3 Computer, IO-Tablet (touch screen) and the monitor).
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-1493-2014·2014-04-30

    Stryker PenAdapt Electrosurgical Accessory Recalled for Sterile Barrier Breach

    Stryker is recalling 35,310 PenAdapt electrosurgical accessories due to packaging cuts that may breach the sterile barrier and the presence of aluminum shavings.

    Product
    Stryker PenAdapt"; Rx Only, Sterile. This device is an accessory to an electrosurgical unit (ESU). The PenAdapt is used to remove smoke, particles, and body and casual fluids from the point of surgical activity during surgical procedures that use ESU for cutting and cauterizin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1247-2014·2014-03-26

    Stryker Recalls 2.5MM Aggressive Sinuscopic Shaver Blades Due to Missing Scale

    Stryker is voluntarily recalling 90 units of 2.5MM Aggressive Sinuscopic Shaver Blades because the etched line guide is missing the required 1cm to 7cm number scale.

    Product
    2.5MM Aggressive Blade Known as a Sinuscopic Shaver Blade, this device is composed of a metal cutter and plastic drive shaft that goes into a metal housing supported by a plastic hub. ENT Precision Cutter, Aggressive, ESSxlHUMMER 4, Rx Only It is used for ENT procedures and
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0903-2014·2014-02-12

    Stryker Neptune 2 Rover Ultra Waste Management System Field Upgrade

    Stryker is upgrading Neptune 2 Rover Ultra Waste Management Systems in the field to meet new 510(k) clearance specifications.

    Product
    Neptune 2 Rover Ultra Waste Management System
    Category
    Medical Device
    Distribution
    Distributed nationwide