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Stryker Orthopaedics

Country not established

Devices
24
FDA recalls
66 ongoing

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Stryker Orthopaedics makes

Stryker Orthopaedics manufactures orthopaedic implants for hip and knee replacements, including femoral stems, acetabular shells, knee components, and patellar replacements. Products include modular hip systems like the Insignia and Exeter femoral stems, posterior-stabilized knee implants such as the Triathlon system, and metal-backed patellas. Specialized tools like the Exeter Centralizer and femoral heads for hip systems are also part of the portfolio.

These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company’s products are listed in the FDA’s 510(k) database. Stryker Orthopaedics is headquartered in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue24

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FDA recalls6

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 6 recalls initiated by Stryker Orthopaedics, initiated on 2024-04-15. By recorded status: 6 ongoing. The reasons filed fall into these groups: software or firmware. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 6
  • 2025 0
  • 2026 0

  • 2024

    • 15 Apr 2024 Z-1910-2024 Class II Ongoing Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not performed prior to switching between applications (i.e. TKA to THA), resulting in delay in treatment Distribution: Worldwide - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, Columbia, Denmark,…
      Full distribution text Worldwide - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, Columbia, Denmark, Finland, France, Germany, Greece, India, Israel, Italy, Japan, Korea, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Puerto Rico, Qatar, Romania, Saudi Arabia, Singapore, Spain, South Africa, Sweden, Switzerland, Thailand, Turkey, UAE, and UK
      Submission numbers: K172301, K193515, K220459
    • 15 Apr 2024 Z-1911-2024 Class II Ongoing Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not performed prior to switching between applications (i.e. TKA to THA), resulting in delay in treatment Distribution: Worldwide - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, Columbia, Denmark,…
      Full distribution text Worldwide - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, Columbia, Denmark, Finland, France, Germany, Greece, India, Israel, Italy, Japan, Korea, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Puerto Rico, Qatar, Romania, Saudi Arabia, Singapore, Spain, South Africa, Sweden, Switzerland, Thailand, Turkey, UAE, and UK
      Submission numbers: K172301, K193515, K220459
    • 15 Apr 2024 Z-1912-2024 Class II Ongoing Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not performed prior to switching between applications (i.e. TKA to THA), resulting in delay in treatment Distribution: Worldwide - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, Columbia, Denmark,…
      Full distribution text Worldwide - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, Columbia, Denmark, Finland, France, Germany, Greece, India, Israel, Italy, Japan, Korea, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Puerto Rico, Qatar, Romania, Saudi Arabia, Singapore, Spain, South Africa, Sweden, Switzerland, Thailand, Turkey, UAE, and UK
      Submission numbers: K172301, K193515, K220459
    • 15 Apr 2024 Z-1913-2024 Class II Ongoing Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not performed prior to switching between applications (i.e. TKA to THA), resulting in delay in treatment Distribution: Worldwide - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, Columbia, Denmark,…
      Full distribution text Worldwide - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, Columbia, Denmark, Finland, France, Germany, Greece, India, Israel, Italy, Japan, Korea, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Puerto Rico, Qatar, Romania, Saudi Arabia, Singapore, Spain, South Africa, Sweden, Switzerland, Thailand, Turkey, UAE, and UK
      Submission numbers: K172301, K193515, K220459
    • 15 Apr 2024 Z-1914-2024 Class II Ongoing Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not performed prior to switching between applications (i.e. TKA to THA), resulting in delay in treatment Distribution: Worldwide - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, Columbia, Denmark,…
      Full distribution text Worldwide - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, Columbia, Denmark, Finland, France, Germany, Greece, India, Israel, Italy, Japan, Korea, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Puerto Rico, Qatar, Romania, Saudi Arabia, Singapore, Spain, South Africa, Sweden, Switzerland, Thailand, Turkey, UAE, and UK
      Submission numbers: K172301, K193515, K220459
    • 15 Apr 2024 Z-1915-2024 Class II Ongoing Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not performed prior to switching between applications (i.e. TKA to THA), resulting in delay in treatment Distribution: Worldwide - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, Columbia, Denmark,…
      Full distribution text Worldwide - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, Columbia, Denmark, Finland, France, Germany, Greece, India, Israel, Italy, Japan, Korea, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Puerto Rico, Qatar, Romania, Saudi Arabia, Singapore, Spain, South Africa, Sweden, Switzerland, Thailand, Turkey, UAE, and UK
      Submission numbers: K172301, K193515, K220459

Frequently asked questions

How many devices does Stryker Orthopaedics have in the registry?

The registry currently lists 24 devices for Stryker Orthopaedics. Devices recorded under merged duplicate company entries are counted once.

Which registries list Stryker Orthopaedics's devices?

Among its 24 most recently registered devices, Stryker Orthopaedics has devices listed in FDA 510(k) (24 devices).

What risk classes do Stryker Orthopaedics's devices fall under?

Among its 24 most recently registered devices, the classes recorded for Stryker Orthopaedics's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Stryker Orthopaedics?

FDA recall records list 6 recalls initiated by Stryker Orthopaedics, the most recent initiated on 15 Apr 2024. 6 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Stryker Orthopaedics in the registry?

The most recently registered devices listed for Stryker Orthopaedics include SIMPLEX P BONE CEMENT, SHORT CITATION FEMORAL STEM, Insignia Hip Stem and EXETER Centralizer, EXETER 2.5mm Plug.

Generated automatically from registry data and not verified by a human reviewer.