Mako Surgical Corporation recalls RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.

Recall date

December 1, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1644-2018

FDA classification

Class II

Brand / firm

Mako Surgical Corporation

Sold / distributed

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

Why it was recalled

Incorrect product and/or label. Sizing is labeled incorrectly.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.