Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and Recalled by Mako Surgical Corporation Due to Incorrect product and/or label. Sizing is labeled incorrectly.
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 TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.
Quantity: 126
Why Was This Recalled?
Incorrect product and/or label. Sizing is labeled incorrectly.
Where Was This Sold?
This product was distributed to 31 states: AL, AZ, AR, CA, CO, FL, GA, ID, IL, IN, KS, LA, MD, MA, MI, MN, NE, NH, NJ, NY, NC, OK, OR, PA, RI, SC, TX, UT, VA, WA, WY
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