The Recall Desk
HighFDA (Devices)·Z-1912-2024·Announced 2024-06-05

Mako 3.0 and 3.1 surgical systems software error causes treatment delays

Stryker Orthopaedics recalls Mako 3.0 and 3.1 surgical systems due to software errors that cause treatment delays when switching applications without system restart.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Class II device recall affecting surgical robotics equipment. Software error causing treatment delays during orthopedic procedures represents a risk-of-harm situation in a surgical context, even though no injuries have been reported.

Plain-English summary

Stryker Orthopaedics is recalling Mako 3.0 (part number 209999) and Mako 3.1 (part number 219999) surgical systems with specific versions of application software (TKA 2, TKA 1, PKA 3, THA 4.0, 4.1). These robotic-assisted systems are used for orthopedic surgical procedures including total knee arthroplasty, partial knee arthroplasty, and total hip arthroplasty.

The systems have been observed to produce an increased number of Software Error #3 (SE3) error codes when the Mako System is not shut down and restarted before switching between different surgical applications. For example, switching from TKA (knee) mode to THA (hip) mode without performing a system restart triggers the error. When this error occurs, it results in delays in treatment.

The recall affects 20 units distributed worldwide, including throughout the United States and in 34 additional countries including Australia, Austria, Belgium, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, Greece, India, Israel, Italy, Japan, Korea, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Puerto Rico, Qatar, Romania, Saudi Arabia, Singapore, Spain, South Africa, Sweden, Switzerland, Thailand, Turkey, the United Arab Emirates, and the United Kingdom.

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.fr.1+TKA 1.0.1.fr.1+PKA3.0.2.fr. Application Part Number: 700002190743-04
Manufacturer
Stryker Orthopaedics
Category
Medical Device — Surgical robotics / Orthopedic surgery
Hazard
  • software-error
  • treatment-delay

Distribution

Distributed nationwide across the United States.

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