Stryker recalls specific knee and hip implants with software error that delays treatment if system isn't restarted properly. Affected models include TKA 2, TKA 1, 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 certain knee and hip implants that have a software error causing treatment delays if the Mako system isn't restarted properly between surgeries. This could lead to longer wait times for patients needing joint replacements.
The software error occurs when switching between different surgical applications on the Mako system without restarting it first. This causes the system to delay treatment by increasing the Software Error #3 code, which may lead to longer wait times for patients needing joint replacements.
Patients who have received or are scheduled for surgery with the specific Stryker knee or hip implants listed in the recall. Surgeons using the affected Mako systems are most at risk of treatment delays.
Check if your implant has the model numbers TKA 2, TKA 1, PKA 3, or Total Hip on Mako 3.0 or 3.1 systems. The software version includes TKA 2.0, TKA 1.0.1, THA 4.0.0.1, and PKA 3.0.2.
Identify if your implant is one of the recalled models: TKA 2, TKA 1, PKA 3, or Total Hip on Mako 3.0 or 3.1 systems.
No, the recall does not require immediate discontinuation. The software error causes treatment delays if the system isn't restarted properly, but the implants themselves are safe to use.
Contact Stryker Orthopaedics directly to confirm your implant model and get instructions on next steps. The recall does not include a specific remedy for the implants.
The recall describes a software error that causes treatment delays, not a risk of injury. There is no mention of physical harm in the official notice.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1910-2024 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1910-2024 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.
