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Mako Surgical Corporation recalls Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replac
Recalled March 9, 2016 · FDA recall Z-1031-2016 · Mako Surgical
Hazard
Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell packaging configuration exhibited damage, compromising the sterile barrier. · FDA Class II
Units
146
Sold at
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.
Description
Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell packaging configuration exhibited damage, compromising the sterile barrier.
Product
Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO.
Manufacturer(s)
Mako Surgical Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →