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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 10 of 12 Results
510(K) Number: K121064
 
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Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Ar... 2 09/09/2022 Mako Surgical Corporation
Stryker Mako Vizadisc Hip Procedure Tracking Kit 2 08/24/2018 Mako Surgical Corporation
Total Hip Application (THA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) ... 2 09/13/2017 Mako Surgical Corporation
MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery. 2 03/07/2017 Mako Surgical Corporation
Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: The handle is used to h... 2 02/11/2017 Mako Surgical Corporation
MAKOplasty Hip Array Kit Laminate 150230 2 04/29/2016 Mako Surgical Corporation
RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons specifically for the purpos... 2 04/28/2016 Mako Surgical Corporation
Robotic Arm Interactive Orthopedic System (RIO) 2 04/18/2016 Mako Surgical Corporation
Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (co... 2 11/05/2015 Mako Surgical Corporation
RESTORIS PST Acetabular Offset Shell Impactors An impactor is a reusable instrument designed for us... 2 12/18/2014 Mako Surgical Corporation
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