Mako Surgical Corporation recalls Restoris MCK Onlay Insert Extractor.

Recall date

January 19, 2018

Source

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

Recall number

Z-2051-2018

FDA classification

Class II

Brand / firm

Mako Surgical Corporation

Sold / distributed

Distributed domestically to AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, MD, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, WI. Distributed internationally to Australia, China, Italy, Netherlands, Singapore, South Africa, Taiwan, Turkey, United Kingdom.

Why it was recalled

Possible hinge pin disassociation from the Mako Onlay Insert Extractor.

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 Onlay Insert Extractor.