Mako Surgical Corporation recalls Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: The handle is used to hold surgical components…

Recall date

September 29, 2016

Source

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

Recall number

Z-1193-2017

FDA classification

Class II

Brand / firm

Mako Surgical Corporation

Sold / distributed

Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NM, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI, WV, & WY and the countries of Italy, Germany, Australia, China, Europe, Hong Kong, South Africa, Germany, T…

Why it was recalled

Failure of the Offset Cup Reamer Handle not engaging its mating components.

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

What was recalled

Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: The handle is used to hold surgical components during acetabular reaming in MAKO Total Hip procedures.