Mako Surgical Corporation recalls MAKOplasty Hip Array Kit Laminate 150230

Recall date

November 25, 2015

Source

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

Recall number

Z-1588-2016

FDA classification

Class II

Brand / firm

Mako Surgical Corporation

Sold / distributed

CO, KY, MN, WA and WV

Why it was recalled

Stryker Orthpaedics became aware that there is the potential for the 210540 MAKOplasty Hip Array Kit Laminate 150230 to list two part numbers for the RIO Base Array, which is item #5 on the product table.

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

What was recalled

MAKOplasty Hip Array Kit Laminate 150230