Home / Recalls / Medical Devices
Mako Surgical Corporation recalls Restoris MCK Onlay Insert Extractor.
Recalled June 13, 2018 · FDA recall Z-2051-2018 · Mako Surgical
Hazard
Possible hinge pin disassociation from the Mako Onlay Insert Extractor. · FDA Class II
Units
575 units total (400 US, 175 OUS)
Sold at
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.
Description
Possible hinge pin disassociation from the Mako Onlay Insert Extractor.
Product
Restoris MCK Onlay Insert Extractor.
Manufacturer(s)
Mako Surgical Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →