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.
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 3/5 (High).
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
- Affected units
- 20
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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