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Devices
Device Recall Restoris MCK Onlay Insert Extractor
Model / Serial
Item No. 160430, Lot No. 19020414, 19090616, 19090915, 19100616, 19100915, 19110317, 19110616, 19110915, 19130315, 19140315, 19451016, 19461016, 19471016, 19490515, 19500515, 19510515, 19520515, 19530515, 26051212, 26070512, 26080913, 26110512, 26120512, 26130512, 26170513, 26201111, 26290412, 26330712, 26340312, 26440912.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
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.
Product Description
Restoris MCK Onlay Insert Extractor.
Manufacturer
Mako Surgical Corporation
1 Event
Recall of Device Recall Restoris MCK Onlay Insert Extractor
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Manufacturer
Mako Surgical Corporation
Manufacturer Address
Mako Surgical Corporation, 2555 Davie Rd Ste 110, Davie FL 33317-7424
Source
USFDA
Language
English
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