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RobotRisk / Stryker Mako / 2018-07
medical robotics · recall

Stryker Mako Restoris MCK knee implant lawsuit removed to federal court (Perry v. Stryker/Mako)

S2 · 07/2018 · Stryker Mako

Record

CompanyStryker Mako
Categorymedical robotics
Typerecall
Date07/2018
Time of daynot documented
Locationno physical site (recall / fleet-wide / aggregate record)
SeverityS2 (minor injury or single-unit damage)
Scaleindividual implant failure, part of broader MCK litigation
Confidencelow
VerificationYes - adversarially checked against the cited source
SourceAboutLawsuits.com

What happened

A knee implant lawsuit alleged the Mako Restoris Multicompartmental Knee (MCK) implant system, designed for use with Mako robotic-assisted surgery, failed less than a year after implantation, requiring hospitalization and revision surgery; the case was removed to federal court as part of a broader implant-failure litigation.

Stryker Mako record context

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14292018 S2: 11182020 S3: 1919202021 S3: 2929212022 S2: 12022 S3: 1213222023 S3: 1616232024 S3: 1515242025 S3: 2727252026 S3: 152026 S4: 11626
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medical robotics: failure modes

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recall context

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recall: severity profile

Comparable recall events in medical robotics

SevDateCompanyEvent
S22026-06-09CMR SurgicalClass II recall of Versius surgeon console over disabled Secure Boot cybersecurity control
S42026-03-25OmnicellFDA Class I recall: Rolls of label stock used with the Omnicell i.v.Station.
S52026-03-11Intuitive SurgicalClass I recall of da Vinci SureForm stapler reloads after patient death
S32026-01-21Auris Health (J&J MedTech)FDA Class II recall: MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-0
S32025-09-12Noah MedicalFDA Class II recall: Brand Name: Galaxy System
S32025-05-23Quantum SurgicalFDA Class II recall: EPIONE Model 30-0001
S32025-04-23Virtual IncisionFDA Class II recall: MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical sur
S32025-02-26Intuitive SurgicalClass II recall of da Vinci 5 foot pedal over spring failure

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