Mako robotic surgery system software error causes treatment delays
Stryker Mako robotic surgery software exhibits increased Error #3 when switching between surgical applications without system restart, resulting in treatment delays. No patient injuries reported.
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 a Class II medical device recall with no reported patient injuries, deaths, or hospitalizations. The hazard is a software operational defect causing treatment delays rather than direct patient harm. Per the severity rubric, Class II recalls without reported adverse events are classified as Moderate.
Plain-English summary
Stryker Orthopaedics is recalling software designed for Mako 3.0 and 3.1 robotic-assisted surgical systems. The affected software supports Total Knee Arthroplasty (TKA), Partial Knee Arthroplasty (PKA), and Total Hip Arthroplasty (THA) procedures.
The software exhibits an increased frequency of Software Error #3 (SE3) when users switch between surgical applications without first performing a complete system shutdown and restart. When this error occurs, it results in delays to surgical treatment.
The affected software has been distributed worldwide to hospitals and surgical centers in the United States and numerous other countries, including Canada, Australia, and countries throughout Europe, Asia, the Middle East, Africa, and Central/South America.
Healthcare providers using affected Mako systems should contact Stryker Orthopaedics for guidance on addressing this issue and any available software updates or mitigation procedures.
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.es.1 + PKA 3.0.2.es.1 + THA 4.0. Application Part Number: 700002190743-05
- Manufacturer
- Stryker Orthopaedics
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 (2)
- AB
- & AC.
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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