FDA-Device2018-05-16Class II
RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.
Mako Surgical Corporation
Hazard
Incorrect product and/or label. Sizing is labeled incorrectly.
Sold states
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
Affected count
126
Manufactured in
2555 Davie Rd Ste 110, N/A, Davie, FL, United States
Products
RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1644-2018Don't want to check this manually?
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