Mako Surgical recalls

Mako Surgical has 27 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 21 Sep 2022.

Total recalls27since 2012

Last 12 months0reported

Class I00% of total

Ongoing0latest 21 Sep 2022

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 27 100%Class III 0 0%

Why mako surgical is recalled

Product types

Hip & Knee Implants2593%
Other Medical Devices27%

By year

202214%
202027%
201927%
2018622%
2017519%
2016415%
201527%
2014415%
201214%

All mako surgical recalls, newest first

27 total

Reported	Class	Recall	Company	Reason	Where
21 Sep 2022Device	CLASS II	Stryker USB Converter, Polaris Spectra Camera recalled by Mako Surgical	Mako Surgical	Device Malfunction	AZ, IL
25 Nov 2020Device	CLASS II	Mako Integrated Cutting System (MICS) Handpiece recalled	Mako Surgical	Device Malfunction	Nationwide
12 Aug 2020Device	CLASS II	Mako Hip End Effector, Variable Angle recalled by Mako Surgical	Mako Surgical	Other	8 states
26 Jun 2019Device	CLASS II	7 Degree Straight Sagittal Saw attachment recalled by Mako Surgical	Mako Surgical	Other	13 states
26 Jun 2019Device	CLASS II	7 Degree Angled Sagittal Saw attachment recalled by Mako Surgical	Mako Surgical	Other	13 states
26 Sep 2018Device	CLASS II	Makoplasty RIO Standard System recalled by Mako Surgical	Mako Surgical	Other	Nationwide
5 Sep 2018Device	CLASS II	Stryker Mako Vizadisc Hip Procedure Tracking Kit recalled	Mako Surgical	Other	35 states
5 Sep 2018Device	CLASS II	Stryker Mako Vizadisc Knee Procedure Tracking Kit recalled	Mako Surgical	Other	35 states
22 Aug 2018Device	CLASS II	Rio System Irrigation Clip recalled by Mako Surgical	Mako Surgical	Device Malfunction	Nationwide
13 Jun 2018Device	CLASS II	Restoris MCK Onlay Insert Extractor recalled by Mako Surgical	Mako Surgical	Other	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.