Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
MAKO RIO THA Application User Guides Recalled by Mako Surgical Corporation Due to Five (5) AFMEA Risk Control Measures are missing...
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
MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.
Quantity: 777
Why Was This Recalled?
Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides
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