{"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":"reviewed","modelId":null,"deploymentId":null,"companyId":"661fbd42-9fcb-4d47-8a74-7a23d161d57b","dataCenterId":null,"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,"oshaRecordable":null,"oshaCaseNumber":null,"rootCauseDisclosed":null,"publicDisclosureDate":null,"insuranceClaimPublic":null,"formFactor":null,"latitude":null,"longitude":null,"autonomyClass":null,"legalOutcomeClass":"unknown","createdAt":"2026-06-27T09:38:44.530Z","updatedAt":"2026-08-09T05:24:01.599Z","model":null,"deployment":null,"company":{"id":"661fbd42-9fcb-4d47-8a74-7a23d161d57b","name":"Stryker","slug":"stryker","description":"Stryker Corporation (NYSE: SYK) is one of the world's largest medical technology companies, headquartered in Kalamazoo, Michigan, with $25B in 2025 revenue and approximately 56,000 employees. The company's Mako SmartRobotics platform is the leading robotic orthopedic surgery system, with record Mako installations in 2024 for hip and knee replacements, and the next-generation Mako showcased at AAOS 2025 including the new Mako Shoulder application.","status":"public (NYSE: SYK)","founded":1941,"hq":"Kalamazoo, MI, USA","hqLat":42.291707,"hqLng":-85.5872286,"hqGeocodedAt":"2026-08-05T14:49:47.923Z","hqAddress":null,"hqPrecision":null,"website":"stryker.com","fundingTotal":null,"type":"both","reviewStatus":"reviewed","lifecycleState":"active","supersededByCompanyId":null,"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"},{"label":"CEO","value":"Kevin Lobo (Chair & CEO)"},{"label":"Revenue","value":"$25B (2025)"},{"label":"Stock","value":"NYSE: SYK"},{"label":"Employees","value":"approximately 56,000"},{"label":"Robotics platform","value":"Mako SmartRobotics (hip, knee, shoulder)"},{"label":"Mako platform","value":"Hip, Knee, Spine, Shoulder + Mako RPS handheld (2026)"},{"label":"Mako price","value":"$800,000-$1,400,000 (Mako 4 next-gen)"}],"aliases":["Stryker Corporation","MAKO Surgical","Stryker Corp","Mako","Stryker Mako"],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"factoryLocations":null,"manufacturingCapacity":null,"orgType":null,"burnSignal":null,"litigationEvents":null,"insurancePostureDisclosed":null,"unitEconomicsDisclosed":null,"tickerSymbol":"SYK","stockExchange":"NYSE","secCik":"0000310764","revenueUsd":"25000000000","revenueBasis":"reported","revenueAsOf":"2025-12-31T12:00:00.000Z","employeeCount":null,"employeeCountBasis":null,"employeeCountAsOf":null,"marketCapUsd":null,"marketCapAsOf":null,"marketCapSource":null,"createdAt":"2026-06-04T04:09:25.399Z","updatedAt":"2026-08-05T14:52:25.760Z"},"derived":{"status":"active"},"sources":[{"id":"9412aeee-e117-46cb-9df0-224056db6802","incidentId":"b4b54ada-2543-4202-bdd9-9c85e5be5ed4","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?start_search=1&firmlegalnam=Stryker&productdescriptiontxt=Mako&postdatefrom=01/01/2017&postdateto=12/31/2026&PAGENUM=100","label":null,"publishedAt":null,"notes":null,"title":"FDA Medical Device Recalls — Stryker Mako (2017-2026)","sourceName":"FDA","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-22T01:56:11.509Z","updatedAt":"2026-07-22T01:56:11.509Z"}],"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":"verified","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":1,"primary_source_types":["primary-fda-database"]}}}