Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for Recalled by Mako Surgical Corporation Due to Reports where the Mylar/Tyvek pouch for RESTORIS MCK...
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
Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO.
Quantity: 146
Why Was This Recalled?
Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell packaging configuration exhibited damage, compromising the sterile barrier.
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