FDA Recall: Delay in Treatment with Software Shutdown Error

Company: Stryker Orthopaedics
Date of Enforcement Report: 5/28/2024
Class II


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 + PKA 3.0.2 Application Part Number: 700001590415

Recall Number:



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.


Stryker Orthopaedics


334 units


Worldwide – US Nationwide and the countries of Australia, Canada, Chile, China, Columbia, India, Japan, Korea, Malaysia, Mexico, Sweden, Singapore, Thailand, and Netherlands.

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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