Stryker Mako Surgical Robot Software Error Causes Treatment Delays
Stryker's Mako surgical robots may experience software errors causing treatment delays when switching between surgical modes without proper system restart. This affects 334 units globally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses, injuries, or hospitalizations. The hazard is a software operational issue causing treatment delays rather than a direct physical safety hazard, making it a functional/precautionary recall without reported harm.
Plain-English summary
Stryker Orthopaedics has recalled Mako 3.0 and Mako 3.1 surgical robot systems due to a software error that may cause treatment delays. The error occurs when operators switch between different surgical applications—such as knee replacement (TKA), hip replacement (THA), or partial knee replacement (PKA)—without properly shutting down and restarting the system first.
The software issue, identified as Error Code SE3, increases in frequency when procedures are switched without the required system restart. This can cause delays in surgical procedures.
The recall affects 334 units distributed worldwide, including throughout the United States and 35 other countries. Stryker advises healthcare facilities to ensure the system is fully shut down and restarted before switching between different surgical application types.
The recalled product
- Product
- Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0 + TKA 1.0.1 + THA 4.0.0.1 + PKA 3.0.2 Application Part Number: 700001590415
- Manufacturer
- Stryker Orthopaedics
- Affected units
- 334
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- AB
- AC
- & AD.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Stryker Orthopaedics under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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