Mako Surgical Recalls Robotic Knee System Due to Software Display Error
Mako Surgical Corporation is recalling the Makoplasty Partial Knee Application software because it may fail to display all necessary constants when the screen is full.
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: The recall involves a medical device software defect that could affect surgical guidance, representing a risk-of-harm product where injury has not yet been reported, consistent with the 'High' severity criteria.
Plain-English summary
Mako Surgical Corporation is recalling the Makoplasty Partial Knee Application (PKA) software for the Robotic Arm Interactive Orthopedic System (RIO). The recall is due to a software discrepancy where the system may not display all essential engineering (EE) constants when the screen is filled.
The RIO system is intended to assist surgeons by providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The affected software is distributed worldwide, including nationwide in the United States and in various international locations.
The recall covers 349 units in the US and 78 units outside the US. All lot codes are affected. The source text does not report any specific injuries or illnesses associated with this software discrepancy.
The recalled product
- Product
- Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic
- Manufacturer
- Mako Surgical Corporation
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 (1)
- All Lot codes
Distribution
Part of a larger recall action
This product is one of 2 recalled by Mako Surgical Corporation 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.
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