The Recall Desk
ModerateFDA (Devices)·Z-1915-2024·Announced 2024-06-05

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.

What this means for you

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
Category
Medical Device — Robotic Surgery System
Hazard

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

Same manufacturer · Stryker Orthopaedics

See all →

Same hazard · software error

See all →