Stryker recalls certain knee and hip implants with software error #3 that may delay treatment if not properly managed after system restarts. Affected models include TKA 1, TKA 2, PKA 3, and Total Hip implants on Mako 3.0 and 3.1 systems.
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 which can delay treatment if the surgical system isn't restarted properly between procedures. This issue affects implants used with Mako 3.0 and 3.1 systems.
The software error #3 occurs when the Mako surgical system isn't properly restarted between different procedures, like switching from knee to hip surgery. This can cause delays in treatment for patients needing the implants.
Patients who received the recalled knee or hip implants from Stryker, specifically those with TKA 1, TKA 2, PKA 3, or Total Hip implants on Mako 3.0 or 3.1 systems. Surgeons and medical staff using these implants are most at risk of treatment delays.
Check if your implant has the model names TKA 1, TKA 2, PKA 3, or Total Hip on Mako 3.0 or 3.1 systems. The software version should be TKA 2.0.it.1, TKA 1.0.1.it.1, or PKA 3.0.2.it.
Verify your implant's software version matches TKA 2.0.it.1, TKA 1.0.1.it.1, or PKA 3.0.2.it.
Reach out to Stryker Orthopaedics for guidance on whether your implant is affected and next steps.
No, the recall does not require stopping use. The issue is about potential treatment delays if the system isn't restarted properly.
Contact Stryker Orthopaedics directly to confirm if your implant is affected and get instructions for next steps.
The recall describes a potential delay in treatment, not a risk of serious injury. This is a low-risk issue.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1913-2024 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1913-2024 from Stryker. 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.
