{"id":"b4b54ada-2543-4202-bdd9-9c85e5be5ed4","slug":"stryker-mako-mics-handpiece-checkpoint-verification-recall-2020","kind":"recall","headline":"Stryker recalls Mako Integrated Cutting System handpiece over checkpoint-verification flaw that could cause off-plan bone cuts","summary":"A characterization issue with the Mako MICS Handpiece (mounted on the distal end of the Mako robotic arm for bone preparation in total and partial knee procedures) could cause unsuccessful checkpoint verification of the saw blade and a discrepancy during bone preparation, so the surgeon could make cuts differing from the preoperative plan. Distinct from the 2024 Mako Total Knee software 'error #3' recall. Source: FDA Class 2 device recall Z-0472-2021, accessdata.fda.gov.","occurredAt":"2020-10-23T00:00:00.000Z","reviewStatus":"unreviewed","modelId":null,"deploymentId":null,"companyId":"661fbd42-9fcb-4d47-8a74-7a23d161d57b","aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"serious","rootCauseCategory":null,"rootCauseDetail":null,"affectedUnitsCount":null,"affectedUnitsBasis":null,"remediationStatus":null,"regulatoryAction":"recall_ordered","regulatoryBody":"FDA","propertyDamageEstimateUsd":null,"damageEstimateBasis":null,"bodilyInjurySeverity":null,"fatalityCount":null,"lossCostClass":null,"sourceQualityTier":2,"createdAt":"2026-06-27T09:38:44.530Z","updatedAt":"2026-06-27T09:38:44.530Z","model":null,"deployment":null,"company":{"id":"661fbd42-9fcb-4d47-8a74-7a23d161d57b","name":"Stryker","slug":"stryker","description":"Stryker is an American medical technology company based in Kalamazoo, Michigan, developing surgical robots including the Mako SmartRobotics system for orthopedic surgery. Mako provides robotic-arm-assisted hip and knee replacement with haptic guidance.","status":"public (NYSE: SYK)","founded":1941,"hq":"Kalamazoo, MI","fundingTotal":null,"type":"both","reviewStatus":"reviewed","sources":[{"url":"https://investors.stryker.com/press-releases/news-details/2013/Stryker-Announces-Definitive-Agreement-to-Acquire-MAKO-Surgical-Corp-for-165-Billion/default.aspx","title":"Stryker to acquire MAKO Surgical for $1.65B ($30/share; announced Sep 25 2013, closed Dec 17 2013)","sourceName":"Stryker Investor Relations"},{"url":"https://www.sec.gov/Archives/edgar/data/0000310764/000031076426000010/syk-20251231.htm","title":"Stryker Form 10-K FY2024: >1M robotic Mako Total Knees + 1.5M total Mako procedures, 45+ countries; 'one of four leading global competitors'","sourceName":"SEC EDGAR"},{"url":"https://investors.stryker.com/press-releases/news-details/2015/Stryker-Receives-FDA-Clearance-For-Mako-Total-Knee-Application/default.aspx","title":"Stryker receives FDA clearance for Mako Total Knee application (Aug 6 2015)","sourceName":"Stryker Investor Relations"}],"keyFacts":[{"label":"Product","value":"Mako SmartRobotics robotic-arm orthopedic system (knee/hip/spine/shoulder)."},{"label":"Boundary","value":"AI-augmented surgeon-controlled assistance, NOT autonomous."},{"label":"Stock ticker","value":"NYSE: SYK"},{"label":"Market position","value":"Mako SmartRobotics is the market-leading robotic-arm system for orthopedic joint replacement"},{"label":"Acquisition","value":"Acquired MAKO Surgical in 2013 for ~$1.65B"}],"aliases":["Stryker Corporation","MAKO Surgical"],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"createdAt":"2026-06-04T04:09:25.399Z","updatedAt":"2026-07-03T17:29:27.990Z"},"derived":{"status":"active"},"sources":[],"responses":[],"statusEvents":[],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/stryker-mako-mics-handpiece-checkpoint-verification-recall-2020","url":"https://registry.deploy.report/incidents/stryker-mako-mics-handpiece-checkpoint-verification-recall-2020","headline":"Stryker recalls Mako Integrated Cutting System handpiece over checkpoint-verification flaw that could cause off-plan bone cuts","description":"A characterization issue with the Mako MICS Handpiece (mounted on the distal end of the Mako robotic arm for bone preparation in total and partial knee procedures) could cause unsuccessful checkpoint verification of the saw blade and a discrepancy during bone preparation, so the surgeon could make cuts differing from the preoperative plan. Distinct from the 2024 Mako Total Knee software 'error #3' recall. Source: FDA Class 2 device recall Z-0472-2021, accessdata.fda.gov.","identifier":"b4b54ada-2543-4202-bdd9-9c85e5be5ed4","datePublished":"2020-10-23T00:00:00.000Z","articleSection":"recall","publisher":{"@id":"https://deploy.report/#organization"},"author":{"@id":"https://deploy.report/#organization"}},"framework_metadata":{"framework_schema_version":"0.1.0","verification_status":"unreviewed","maturity_stage":null,"lifecycle_state":null,"architectural_position":{"cohort":null,"sub_cohorts":[]},"within_cohort_verified_vs_claimed_pair":null,"cap_flags":[],"verification_depth":{"sources_count":0,"primary_source_types":[]}}}