Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Total Knee Arthroplasty (TKA) 2 Recalled by Stryker Orthopaedics Due to Application software intended to be deployed on Mako...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Stryker Orthopaedics directly.
Affected Products
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
Quantity: 1,635 units
Why Was This 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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Stryker Orthopaedics
Stryker Orthopaedics has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report