The Recall Desk

FDA (Devices) recall action 94473

Stryker Orthopaedics recalled 6 products on 2024-06-05

The FDA (Devices) publishes a recall like this one as 6 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 6 pages.

Products
6
Announced
2024-06-05
Critical
0
Units
2,097

Why these products were recalled

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

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.

1–6 of 6

  • HighFDA (Devices)··2024-06-05

    Stryker Mako Surgical System Software Error Affects Knee and Hip Replacements

    Stryker Orthopaedics is recalling Mako surgical system software used for knee and hip replacement procedures due to a software error that causes treatment delays when switching between surgical applications without proper system restart.

    Product
    Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1 Software: TKA 2.0.de.1+TKA 1.0.1.de.1+PKA3.0.2.de. Application Part Number: 700002190743-03
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-06-05

    Mako Surgical Robot Software Error Causes Treatment Delay in Orthopedic Surgery

    Stryker Orthopaedics is recalling Mako surgical robot software due to an error that occurs when switching between surgical applications without restarting the system, resulting in treatment delays.

    Product
    Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0 + TKA 1.0.1 + THA 4.1 + PKA 3.0.2 + MGO 1.2.2 Application Part Number: 700001590414
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-06-05

    Mako 3.0 and 3.1 surgical systems software error causes treatment delays

    Stryker Orthopaedics recalls Mako 3.0 and 3.1 surgical systems due to software errors that cause treatment delays when switching applications without system restart.

    Product
    Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software:TKA 2.0.fr.1+TKA 1.0.1.fr.1+PKA3.0.2.fr. Application Part Number: 700002190743-04
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-06-05

    Mako Robotic Surgery Software Error May Delay Orthopedic Treatments

    Stryker Orthopaedics recalls Mako surgical system software versions that can produce error codes requiring system restart before switching between surgical applications, potentially causing treatment delays.

    Product
    Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0.it.1+TKA 1.0.1.it.1+PKA3.0.2.it. Application Part Number: 700002190743-01
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2024-06-05

    Mako robotic surgery system software error causes treatment delays

    Stryker Mako robotic surgery software exhibits increased Error #3 when switching between surgical applications without system restart, resulting in treatment delays. No patient injuries reported.

    Product
    Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1 Software: TKA 2.0.es.1 + PKA 3.0.2.es.1 + THA 4.0. Application Part Number: 700002190743-05
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2024-06-05

    Stryker Mako Surgical Robot Software Error Causes Treatment Delays

    Stryker's Mako surgical robots may experience software errors causing treatment delays when switching between surgical modes without proper system restart. This affects 334 units globally.

    Product
    Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0 + TKA 1.0.1 + THA 4.0.0.1 + PKA 3.0.2 Application Part Number: 700001590415
    Category
    Distribution
    0 states