Mako Surgical Corporation recalls Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacem…

Recall date

January 15, 2016

Source

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

Recall number

Z-1031-2016

FDA classification

Class II

Brand / firm

Mako Surgical Corporation

Sold / distributed

Worldwide Distribution: US (nationwide) including states of: AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, LA, MI, MS, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI, and WY ; and countries of: Italy, Scotland, Turkey, Greece, Germany, and Singapore.

Why it was recalled

Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell packaging configuration exhibited damage, compromising the sterile barrier.

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 Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO.