Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Total Hip Application (THA) Product Usage: The Robotic Arm Interactive Recalled by Mako Surgical Corporation Due to Software discrepancy of not showing all the EE...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Mako Surgical Corporation directly.
Affected Products
Total Hip Application (THA) 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 procedures.
Quantity: 291 (US) and 66 (OUS)
Why Was This Recalled?
Software discrepancy of not showing all the EE constants, when the screen is filled.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Mako Surgical Corporation
Mako Surgical Corporation has 27 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report