Stryker recalls certain knee and hip implants with software error #3 that delays treatment if systems aren't restarted properly. Affected devices may need software updates to prevent treatment delays.
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 is recalling specific knee and hip implants that have a software error causing treatment delays when switching between applications without restarting the system. This could lead to longer wait times for patients needing surgery.
The software error #3 occurs when switching between different surgical applications without first restarting the Mako system. This can cause delays in treatment for patients who need surgery, but does not cause injury or damage to the implants themselves.
Patients with Stryker knee or hip implants using the Mako 3.0 or 3.1 systems are most at risk. Healthcare providers who use these implants for surgery may also be affected.
Check for the Mako 3.0 or 3.1 systems with software versions TKA 2.0.es.1, PKA 3.0.2.es.1, or THA 4.0. The product has part number 700002190743-05 and revisions AA, AB, or AC.
Verify your Mako system software version matches the recalled versions (TKA 2.0.es.1, PKA 3.0.2.es.1, THA 4.0).
The recall affects the software used during surgery planning, not the implants themselves. Patients may experience delays if the system isn't restarted properly between applications.
Check for the Mako 3.0 or 3.1 systems with software versions TKA 2.0.es.1, PKA 3.0.2.es.1, or THA 4.0, and part number 700002190743-05 with revisions AA, AB, or AC.
The recall does not require immediate action. Healthcare providers should check software versions to avoid treatment delays when switching applications.
We’ve drafted a message you can send Stryker Orthopaedics to request your refund or repair — edit it as you like.
Subject: Recall Z-1915-2024 — Stryker Orthopaedics Stryker Orthopaedics Hello, I own a Stryker Orthopaedics that is covered by recall Z-1915-2024 from Stryker Orthopaedics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
