Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) Recalled by Mako Surgical Corporation Due to The locking pin on the RIO Base Array...
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
Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector). Indicated for use in surgical knee resurfacing and total hip Arthroplasty joint replacement procedures.
Quantity: 1,322 units
Why Was This Recalled?
The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector.
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