FDA-Device2018-06-13Class II
Restoris MCK Onlay Insert Extractor.
Mako Surgical Corporation
Hazard
Possible hinge pin disassociation from the Mako Onlay Insert Extractor.
Sold states
Distributed domestically to AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, MD, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, WI. Distributed internationally to Australia, China, Italy, Netherlands, Singapore, South Africa, Taiwan, Turkey, United Kingdom.
Affected count
575 units total (400 US, 175 OUS)
Manufactured in
2555 Davie Rd Ste 110, N/A, Davie, FL, United States
Products
Restoris MCK Onlay Insert Extractor.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2051-2018Don't want to check this manually?
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