{"id":"46e5eb27-ba9d-4cab-839c-51793dcd3e0f","slug":"stryker-mako-bone-registration-recall-2022","kind":"recall","headline":"Stryker Mako bone-registration accuracy recall (Class II, 2022)","summary":"Stryker issued a voluntary field safety corrective action for the Mako SmartRobotics system relating to potential bone surface registration inaccuracies under specific intraoperative conditions. Affected units received software update. FDA classified as Class II recall. Filed in FDA enforcement reports as recall Z-0512-2023 (initiated 2022).","occurredAt":"2022-07-01T00:00:00.000Z","reviewStatus":"reviewed","modelId":"af24ae78-30aa-4141-8260-3cde7639e953","deploymentId":null,"companyId":"661fbd42-9fcb-4d47-8a74-7a23d161d57b","dataCenterId":null,"aliases":[],"collisionRisk":"none","reviewNote":null,"severity":null,"rootCauseCategory":null,"rootCauseDetail":null,"affectedUnitsCount":null,"affectedUnitsBasis":null,"remediationStatus":null,"regulatoryAction":null,"regulatoryBody":null,"propertyDamageEstimateUsd":null,"damageEstimateBasis":null,"bodilyInjurySeverity":null,"fatalityCount":null,"lossCostClass":null,"sourceQualityTier":null,"oshaRecordable":null,"oshaCaseNumber":null,"rootCauseDisclosed":null,"publicDisclosureDate":null,"insuranceClaimPublic":null,"formFactor":"surgical","latitude":{"s":1,"e":1,"d":[55,3781000]},"longitude":{"s":-1,"e":0,"d":[3,4360000]},"autonomyClass":null,"legalOutcomeClass":"unknown","createdAt":"2026-06-11T01:52:00.176Z","updatedAt":"2026-08-09T05:24:01.599Z","model":{"id":"af24ae78-30aa-4141-8260-3cde7639e953","companyId":"661fbd42-9fcb-4d47-8a74-7a23d161d57b","modelName":"Stryker Mako SmartRobotics","slug":"mako-smartrobotics","description":"Robotic arm for knee and hip replacement surgery. AccuStop haptic feedback and patient-specific planning.","formFactor":"surgical","industryVertical":"healthcare","environment":"indoor","maturityStage":"commercial","lifecycleState":"active","supersededByModelId":null,"specs":{},"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://www.stryker.com/","title":"Stryker","date_accessed":"2026-06-07"}],"aliases":[],"collisionRisk":"low","reviewNote":"reverified 2026-06-09 (Kimi-incident remediation): cited primary source resolves and matches manufacturer/reputable domain; relevance adjudicated.","manufacturerTermForTeleop":null,"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)"}],"createdAt":"2026-06-08T00:59:23.133Z","updatedAt":"2026-07-12T04:24:54.291Z","unitsInFieldClaimed":null,"unitsInFieldVerified":null,"unitsManufacturedClaimed":null,"unitsManufacturedVerified":null,"unitsAsOf":null,"unitsSource":null,"salesModel":null,"priceUndisclosedSince":null,"autonomyClass":null,"autonomyStatement":null,"autonomyStatementSource":null,"demoForensics":null,"exportControlClass":null,"minCommitment":null,"warrantyTerms":null,"serviceModel":null,"productionRateClaimed":null,"productionRateEvidenced":null,"teleopRatioDisclosed":null,"interventionRateDisclosed":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":"9ace7cd7-ca8d-49cd-b39f-d91d23678778","incidentId":"46e5eb27-ba9d-4cab-839c-51793dcd3e0f","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":"2026-07-22T01:56:10.591Z","updatedAt":"2026-07-22T01:56:10.591Z"}],"responses":[],"statusEvents":[],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/stryker-mako-bone-registration-recall-2022","url":"https://registry.deploy.report/incidents/stryker-mako-bone-registration-recall-2022","headline":"Stryker Mako bone-registration accuracy recall (Class II, 2022)","description":"Stryker issued a voluntary field safety corrective action for the Mako SmartRobotics system relating to potential bone surface registration inaccuracies under specific intraoperative conditions. Affected units received software update. FDA classified as Class II recall. Filed in FDA enforcement reports as recall Z-0512-2023 (initiated 2022).","identifier":"46e5eb27-ba9d-4cab-839c-51793dcd3e0f","datePublished":"2022-07-01T00:00:00.000Z","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"]}}}