Stryker recalls certain knee and hip implants that may delay treatment if software isn't updated before switching between applications. Affected devices include specific TKA and THA models with 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 could delay treatment if the software isn't updated before switching between applications. This issue affects devices with certain Mako 3.0 and 3.1 systems.
The software error code increases when the Mako system isn't shut down or restarted before switching between applications, like moving from a knee implant procedure to a hip implant procedure. This can delay treatment for patients.
Patients with Stryker knee or hip implants that use Mako 3.0 or 3.1 systems may be affected. Medical professionals using these specific implants are most at risk.
Check for the specific software versions: TKA 2.0.de.1, TKA 1.0.1.de.1, or PKA 3.0.2.de. These are part of Mako 3.0 or 3.1 systems with application part numbers 700002190743-03.
Verify your device's software version matches the affected versions listed in the recall notice.
No, the recall does not require stopping use. The issue is about software updates before switching applications.
The recall does not specify a remedy, so contact Stryker directly for guidance.
Check for the specific software versions: TKA 2.0.de.1, TKA 1.0.1.de.1, or PKA 3.0.2.de. on Mako 3.0 or 3.1 systems with application part number 700002190743-03.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1914-2024 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1914-2024 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.
