Stryker recalls certain knee and hip implants with software error #3 that delays treatment if systems aren't properly restarted. 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 the Mako system isn't restarted properly before switching between different surgical applications. This causes delays in treatment, meaning patients may have to wait longer for their surgery.
Patients with Stryker knee or hip implants that use the Mako 3.0 or 3.1 systems are affected. Those who have recently had surgery or are scheduled for surgery are at higher risk of delayed treatment.
Check if your implant has the software version TKA 2.0.fr.1, TKA 1.0.1.fr.1, or PKA 3.0.2.fr. The product was sold with Mako 3.0 or 3.1 systems between 2020 and 2021.
Verify your implant's software version matches TKA 2.0.fr.1, TKA 1.0.1.fr.1, or PKA 3.0.2.fr.
The recall does not require immediate action. Check your software version to see if you need to update it.
The error causes delays in treatment if the system isn't restarted properly before switching applications, which could mean longer wait times for surgery.
The recall does not mention a specific fix or remedy. You may need to update the software version to resolve the issue.
We’ve drafted a message you can send Stryker Orthopaedics to request your refund or repair — edit it as you like.
Subject: Recall Z-1912-2024 — Stryker Orthopaedics Stryker Orthopaedics Hello, I own a Stryker Orthopaedics that is covered by recall Z-1912-2024 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.
