Stryker recalls certain knee and hip implants that may delay treatment if not properly shut down before switching between applications. Affected devices include specific TKA and THA models with software version 2.0 and 1.0.1.
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 may delay treatment if users don't properly shut down the system before switching between applications. This issue affects devices with certain software versions and part numbers.
The software error #3 (SE3) can occur if the Mako system isn't shut down or restarted before switching between applications, like from knee to hip surgery. This may delay treatment for patients needing the procedure.
Patients using Stryker's Total Knee Arthroplasty (TKA) 1, TKA 2, Partial Knee Arthroplasty (PKA) 3, or Total Hip Arthroplasty (THA) 4.0/4.1 implants with specific software versions. Surgeons and medical staff who operate these devices are most at risk.
Check for the software version numbers: TKA 2.0, TKA 1.0.1, THA 4.1, PKA 3.0.2, or MGO 1.2.2. The part number 700001590414 and revision letters AA, AB, or AC indicate affected devices.
Verify the software version on your device to see if it matches TKA 2.0, TKA 1.0.1, THA 4.1, PKA 3.0.2, or MGO 1.2.2.
Ensure your device has revision letters AA, AB, or AC to confirm it's affected.
No, the recall does not require stopping use. The issue may cause delays in treatment if the system isn't properly shut down before switching applications.
The recall does not provide a remedy. Affected users should check their software version and revision to confirm if they are impacted.
Look for software versions TKA 2.0, TKA 1.0.1, THA 4.1, PKA 3.0.2, or MGO 1.2.2 with part number 700001590414 and revision letters AA, AB, or AC.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1911-2024 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1911-2024 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.
