Mako Robotic Surgery Software Error May Delay Orthopedic Treatments
Stryker Orthopaedics recalls Mako surgical system software versions that can produce error codes requiring system restart before switching between surgical applications, potentially causing treatment delays.
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: This is a Class II medical device recall for a surgical system. No injuries or illnesses are reported, but the software error can delay treatment, which constitutes a risk-of-harm for patients. The error occurs during standard operation and requires a procedural workaround to prevent.
Plain-English summary
Stryker Orthopaedics is recalling specific software versions of the Mako robotic surgical system, a computer-assisted platform used for orthopedic surgery. The software versions operate on Mako 3.0 and 3.1 platforms and support Total Knee Arthroplasty, Partial Knee Arthroplasty, and Total Hip Arthroplasty procedures.
An increase in Software Error #3 (SE3) error code occurrences has been documented when the system is switched between different applications without first completing a full shutdown or system restart. When this occurs, surgical treatment is delayed.
The recall involves 68 units distributed worldwide, including across the United States and to 35 additional countries and territories.
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.it.1+TKA 1.0.1.it.1+PKA3.0.2.it. Application Part Number: 700002190743-01
- Manufacturer
- Stryker Orthopaedics
- Hazard
- Affected units
- 68
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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