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Mako Surgical Corporation recalls RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.
Recalled May 16, 2018 · FDA recall Z-1644-2018 · Mako Surgical
Hazard
Incorrect product and/or label. Sizing is labeled incorrectly. · FDA Class II
Units
126
Sold at
AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, MN, NC, NE, NH, NJ, NY, OK, OR, PA, RI, SC, TX, UT, VA, WA, WY, and Hawaii Australia, Italy, Netherlands, Singapore, South Korea, United Kingdom, and Vietnam
Description
Incorrect product and/or label. Sizing is labeled incorrectly.
Product
RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.
Manufacturer(s)
Mako Surgical Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →