Mako Surgical Robot Software Error Causes Treatment Delay in Orthopedic Surgery
Stryker Orthopaedics is recalling Mako surgical robot software due to an error that occurs when switching between surgical applications without restarting the system, resulting in 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 affecting surgical equipment. Although no injuries or illnesses have been reported, the software error represents a risk of harm by potentially affecting system reliability and surgical treatment delivery in orthopedic procedures.
Plain-English summary
Stryker Orthopaedics is recalling software used in Mako 3.0 and 3.1 surgical robots employed in total knee, total hip, and partial knee replacement surgeries. The affected software versions include TKA 2.0, TKA 1.0.1, THA 4.1, PKA 3.0.2, and MGO 1.2.2.
The recall was initiated because a software error (Error #3) occurs with increased frequency when the Mako system is not shut down and restarted before switching between different surgical applications. For example, if the system switches from a knee replacement application to a hip replacement application without a restart, the error may occur, resulting in delays to surgical treatment.
Approximately 1,635 units have been distributed worldwide to the United States and numerous countries. No injuries or illnesses have been reported in connection with this issue.
Healthcare providers using affected Mako systems should contact Stryker Orthopaedics for guidance on obtaining software updates or implementing recommended workarounds to ensure proper system operation.
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 + TKA 1.0.1 + THA 4.1 + PKA 3.0.2 + MGO 1.2.2 Application Part Number: 700001590414
- Manufacturer
- Stryker Orthopaedics
- Affected units
- 1,635
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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