Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Restoris MCK Onlay Insert Extractor. Recalled by Mako Surgical Corporation Due to Possible hinge pin disassociation from the Mako Onlay...
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 MCK Onlay Insert Extractor.
Quantity: 575 units total (400 US, 175 OUS)
Why Was This Recalled?
Possible hinge pin disassociation from the Mako Onlay Insert Extractor.
Where Was This Sold?
This product was distributed to 29 states: AL, AZ, AR, CA, CO, CT, FL, IL, IN, KS, LA, MD, MI, MN, MO, NE, NV, NH, NJ, NY, NC, OH, OK, OR, PA, TN, TX, UT, WI
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