FDA-Device2016-03-09Class II
Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO.
Mako Surgical Corporation
Hazard
Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell packaging configuration exhibited damage, compromising the sterile barrier.
Sold states
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.
Affected count
146
Manufactured in
2555 Davie Rd Ste 110, N/A, Plantation, FL, United States
Products
Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1031-2016Don't want to check this manually?
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