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.

26–50 of 161

  • SevereFDA (Devices)·Z-1243-2018·2018-04-04

    Stryker Recalls Break-Away Femoral Nozzles Due to Sterility Concerns

    Stryker is recalling 384 Break-Away Femoral Nozzles because bioburden levels were found to be higher than acceptable rates, posing a risk of infection.

    Product
    Break-Away Femoral Nozzle, Product Number: 0206-512-000, UDI: (01)4546540039415 for orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1247-2018·2018-04-04

    Stryker Recalls 11g Verteport Cement Cannula Due to Sterility Concerns

    Stryker is recalling 11g Verteport Cement Cannulas because bioburden levels were found to be higher than acceptable rates, potentially compromising sterility.

    Product
    11g Verteport Cement Cannula (18/pkg), Product Number: 0306-511-000, UDI: (01)7613252594307 for spinal orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1249-2018·2018-04-04

    Stryker Spinal Orthopedic PCD Kit Recalled for Sterility Assurance Issues

    Stryker is recalling 12 units of a spinal orthopedic PCD kit because bioburden levels exceeded internal acceptable rates, compromising sterility assurance.

    Product
    PCD Kit: Long 90, 13g Match-Ground w/ Bevel, Product Number: 0506-485-000, UDI: (01)4546540907035 for spinal orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1244-2018·2018-04-04

    Stryker Recalls 180-Gram Cement Cartridges Due to Sterility Assurance Issues

    Stryker is recalling 708 units of 180-Gram Cement Cartridges with Breakaway Femoral Nozzles because bioburden levels were found to be higher than internal acceptable rates.

    Product
    180-Gram Cement Cartridge with Breakaway Femoral Nozzle, Product Number: 0206-530-000, UDI: (01)4546540857880 for orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1216-2018·2018-04-04

    Stryker Recalls Thoracic Pedicle Feelers Due to Potential Tip Breakage

    Stryker is voluntarily recalling 28 Thoracic Pedicle Feelers because machine settings caused material degradation, creating a risk that the instrument tip may break.

    Product
    The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for remote control of the navigation software and creation of a pathway into the pedicle. The instrument has three types of buttons to remotely control the software: the UP, DOWN and SELECT buttons. The Ped
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1248-2018·2018-04-04

    Stryker Recalls Advanced Cement Mixing Kits Due to Sterility Concerns

    Stryker is recalling 1,542 Advanced Cement Mixing Kits because bioburden levels exceeded acceptable rates, posing a sterility risk.

    Product
    Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press., Product Number: 0306-573-000, UDI: (01)4546540055415 for orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1245-2018·2018-04-04

    Stryker Recalls Femoral Canal Pressurizers Due to Sterility Assurance Issues

    Stryker is recalling specific lots of Femoral Canal Pressurizers because bioburden levels were found to be higher than acceptable rates, potentially compromising sterility.

    Product
    1. Femoral Canal Pressurizer without Hub, Medium, Blue, Product Number: 0206-546-000, UDI: (01)4546540039552; 2. Femoral Canal Pressurizer without Hub, Large, Red, Product Number: 0206-547-000, UDI: (01)4546540039569 for orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1246-2018·2018-04-04

    Stryker InterPulse Handpieces Recalled for Sterility Assurance Issues

    Stryker is recalling InterPulse Handpieces because bioburden levels were found to be higher than internal acceptable rates, indicating a lack of sterility assurance.

    Product
    1. InterPulse Handpiece with coaxial bone cleaning tip, Product Number: 0210-110-100, UDI: (01)4546540861641; 2. InterPulse Handpiece with Coaxial High Flow Tip, Product Number: 0210-114-100, UDI: (01)4546540861764; 3. InterPulse Handpiece with Retractable Coaxial Fan Spray Tip,
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1251-2018·2018-04-04

    Stryker Recalls 30 Revolution 90 Degree Tibial Nozzles for Sterility Issues

    Stryker is recalling 30 units of the Revolution 90 Degree Tibial Nozzle because bioburden levels exceeded acceptable rates, posing a sterility risk.

    Product
    Revolution 90 Degree Tibial Nozzle, Product Number: 0606-516-000, UDI: (01)4546540911971 for orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1255-2018·2018-04-04

    Stryker Recalls Intramedullary Brushes Due to Sterility Assurance Failure

    Stryker is recalling 320 Intramedullary Brushes because bioburden levels exceeded acceptable rates, compromising sterility assurance.

    Product
    Intramedullary Brush Standard O.D. 14 mm, Product Number: 6198-001-514, UDI: (01)4546540255853 for orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1254-2018·2018-04-04

    Stryker iVAS System Kits Recalled for Sterility Assurance Issues

    Stryker is recalling 504 iVAS System Kits for spinal orthopedic use because bioburden levels were found to be higher than internal acceptable rates, indicating a lack of sterility assurance.

    Product
    1. 11g/10mm iVAS System Kit, Product Number: 0705-310-000, UDI: (01)7613252505983; 2. 11g/15mm iVAS System Kit, Product Number: 0705-315-000, UDI: (01)7613252505969 for spinal orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1252-2018·2018-04-04

    Stryker Recalls Orthopedic Cement Mixers Due to Sterility Assurance Issues

    Stryker is recalling 732 units of Revolution CMS orthopedic cement mixers because bioburden levels exceeded internal acceptable rates, compromising sterility assurance.

    Product
    Revolution CMS w/ Femoral Breakaway Nozzle & Med. Press., Product Number: 0606-573-000, UDI: (01)4546540912114 for orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1250-2018·2018-04-04

    Stryker AutoPlex Bone Cement Recalled for Sterility Assurance Issues

    Stryker is recalling AutoPlex bone cement systems because bioburden levels were found to be higher than acceptable rates, potentially compromising sterility.

    Product
    1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. AutoPlex System: w/ VertaPlex HV, Product Number: 0607-687-000, UDI: (01)7613252039259 Bone cement.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2071-2017·2017-05-17

    Stryker PROFESS Registration Kit Recalled for Expiration Date Issues

    Stryker is recalling 65 PROFESS Registration Kits shipped near or past their expiration dates. The kits are used for intranasal and sinus surgery.

    Product
    Stryker PROFESS Registration Kit. The Stryker PROFESS Registration Kit is a member of the Navigation portfolio and is used as an intraoperative guidance system to enable intranasal and sinus computer-assisted surgery. The system is comprised of PROFESS Registration Stickers, a P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1886-2017·2017-05-03

    Stryker SmartLife Large Aseptic Housing Recall for Weld Separation

    Stryker is recalling 302 SmartLife Large Aseptic Housings due to complaints of housing deterioration and weld separation caused by improper cleaning practices.

    Product
    Stryker SmartLife Large Aseptic Housing (7126-120-000)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0870-2017·2016-12-28

    Stryker Recalls Sterile Minimally Invasive Surgery Burs Due to Corrosion

    Stryker is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because they may exhibit signs of corrosion.

    Product
    8470-009-030 3.0MM Precision Round, 16CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases. Each cutting accessory consists of: " A shank (B) with a notch (A), that fits in the attachmen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0874-2017·2016-12-28

    Stryker Recalls Sterile Minimally Invasive Surgery Burs Due to Corrosion

    Stryker is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because they may exhibit signs of corrosion.

    Product
    8450-009-040 4.0MM Precision Round, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases. Each cutting accessory consists of: " A shank (B) with a notch (A), that fits in the attachmen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0873-2017·2016-12-28

    Stryker Recalls Sterile Minimally Invasive Surgery Burs Due to Corrosion

    Stryker is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because they may exhibit signs of corrosion.

    Product
    8450-009-030 3.0MM Precision Round, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases. Each cutting accessory consists of: " A shank (B) with a notch (A), that fits in the attachmen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0869-2017·2016-12-28

    Stryker Recalls Sterile Minimally Invasive Surgery Burs Due to Corrosion

    Stryker is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because they may exhibit signs of corrosion.

    Product
    8450-107-525 2.5MM Precision Match Head, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases. Each cutting accessory consists of: " A shank (B) with a notch (A), that fits in the atta
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0872-2017·2016-12-28

    Stryker Recalls Sterile Minimally Invasive Surgery Burs Due to Corrosion

    Stryker is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because they may exhibit signs of corrosion.

    Product
    8450-010-040 4.0MM Round, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases. Each cutting accessory consists of: " A shank (B) with a notch (A), that fits in the attachment on one
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0871-2017·2016-12-28

    Stryker Recalls Sterile Minimally Invasive Surgery Burs Due to Corrosion

    Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because they may exhibit signs of corrosion.

    Product
    8470-009-040 4.0MM Precision Round, 16CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases. Each cutting accessory consists of: " A shank (B) with a notch (A), that fits in the attachmen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0868-2017·2016-12-28

    Stryker Recalls Sterile Minimally Invasive Surgery Burs Due to Corrosion

    Stryker is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because they may exhibit signs of corrosion.

    Product
    8450-107-530 3.0MM Precision Match Head, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases. Each cutting accessory consists of: " A shank (B) with a notch (A), that fits in the atta
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0112-2017·2016-10-26

    Stryker Recalls Sagittal Blades Due to Potential Sterile Barrier Breach

    Stryker Instruments is voluntarily recalling 225 Sagittal Blades due to a potential sterile barrier breach in the packaging.

    Product
    Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090 Product Usage: Heavy duty Sagittal Blades are used to cut bone and bone related tissue in a variety of orthopedic procedures. Typical procedures include, total-knee, uni-compartmental knee, hip, shoulder and ankle proc
    Category
    Medical Device
    Distribution
    Distributed nationwide