# Major Recall Alert: TKA 2.0 + TKA1.0.1+ THA 4.0.0.1 + PKA 3.0.2 + MGO 1.2.2, TKA 2.0 + TKA1.0.1+ THA 4.1. + PKA 3.0.2 + MGO 1.2.2 Recalled Due to Increased Software Error #3 (se3) Code
On **August 18, 2025**, a major product recall was issued by **Stryker** for their Total Knee Arthroplasty (TKA) 2.0, TKA 1.0.1, Total Hip Arthroplasty (THA) 4.0.0.1, Partial Knee Arthroplasty (PKA) 3.0.2, Mako Guidance Option (MGO) 1.2.2, and other related systems. The recall addresses a critical software error (se3) that may increase in frequency if proper system shutdown or restart is not performed when switching between applications, such as TKA to THA.
This issue raises significant concerns for healthcare professionals who rely on the Mako® systems for precise surgical applications. If you're utilizing these affected systems, here's everything you need to know.
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## Why This Recall is Important
The recall affects cutting-edge orthopedic surgical systems developed by Stryker, a leading medical device manufacturer. These software-controlled systems are integral for procedures such as Total Knee Arthroplasty (TKA) and Total Hip Arthroplasty (THA). When switching applications without properly restarting or shutting down the Mako® system, users have reported an uptick in **software error #3 (se3)**, causing operational disruptions.
### Implications of Software Error #3 (se3):
- **System performance issues:** Interruptions during surgery could delay procedures.
- **Error risks:** The increased error rate may negatively impact surgical accuracy.
- **Patient safety concerns:** Optimal device functionality is essential during critical medical operations.
Failing to address these software glitches could compromise the efficiency of these advanced technologies, emphasizing the importance of adhering to recall guidelines for patient safety and operational success.
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## Details of the Recall
The recall includes the following systems and versions:
- **Affected Brands/Versions:**
- **TKA 2.0 + TKA1.0.1+ THA 4.0.0.1 + PKA 3.0.2 + MGO 1.2.2**
- **TKA 2.0 + TKA1.0.1+ THA 4.1.0.0 + PKA 3.0.2 + MGO 1.2.2**
- **Recall Start Date:** August 18, 2025
- **Issue Identified:** Increased frequency of software error #3 (se3) due to improper shutdown/restart between application switches.
- **Manufacturer:** Stryker
- **Official Government Link:** [View Recall Notice](https://recalls-rappels.canada.ca/en/alert-recall/total-knee-arthroplasty-tka-and-total-hip-arthroplasty-tha)
Make sure to contact the appropriate support channels and review your hospital’s inventory to ensure compliance.
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## What You Should Do
If you or your medical facility uses these Mako® systems, it’s imperative to follow these safety measures:
- **Check Your System Version:** Determine if your system matches the affected versions listed above.
- **Restart or Shut Down Systems:** Always perform a full restart or shutdown when switching between applications like TKA and THA.
- **Report Any Issues:** If errors persist, contact your Stryker representative immediately.
- **Follow Recall Instructions:** Refer to [Canada's official recall notice](https://recalls-rappels.canada.ca/en/alert-recall/total-knee-arthroplasty-tka-and-total-hip-arthroplasty-tha) for further guidance on resolving the issue.
Healthcare organizations should also conduct regular system maintenance and inform their staff about necessary procedural updates to prevent errors. Collaboration with your Stryker representative is crucial to address this issue effectively.
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## Stay Safe – Get Instant Recall Alerts
Medical professionals rely on cutting-edge surgical systems like the Mako® for precision and efficiency, but software errors can pose serious risks. Staying informed about recalls is a critical part of maintaining safety standards in healthcare.
To protect your patients and stay ahead of potential issues, it’s essential to act quickly when recalls are announced. Stay up-to-date on vital recall information by downloading our free **Recall Alert App**. This app provides **real-time notifications** for product recalls across industries, helping professionals mitigate potential risks before they escalate.
[Download the Recall App Now](#) and safeguard your clinical operations today.
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For more information about the **TKA 2.0 + THA 4.0.0.1 recall**, visit the official recall notice here: [Canada Health Recall Notice](https://recalls-rappels.canada.ca/en/alert-recall/total-knee-arthroplasty-tka-and-total-hip-arthroplasty-tha). Stay informed, stay prepared, and stay safe.