Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Stryker Restoris RIO Reamer Handle Recalled by Mako Surgical Corporation Due to Failure of the Offset Cup Reamer Handle not...
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
Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: The handle is used to hold surgical components during acetabular reaming in MAKO Total Hip procedures.
Quantity: 595 units
Why Was This Recalled?
Failure of the Offset Cup Reamer Handle not engaging its mating components.
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