{"id":"1ad4d4b8-1b96-4979-b7b4-840e4b0bc0cf","slug":"stryker-mako-restoris-mck-baseplate-mislabel-recall-2023","kind":"recall","headline":"Stryker recalls Mako Restoris MCK tibial baseplate trials over incorrect size laser marking","summary":"Certain lots of the Mako Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials, used in robotic partial knee arthroplasty, carried incorrect size laser marking, creating a wrong-size component risk. Source: FDA Class 2 device recall Z-1386-2023 (102 units in commerce), accessdata.fda.gov.","occurredAt":"2023-03-10T00:00:00.000Z","reviewStatus":"unreviewed","modelId":null,"deploymentId":null,"companyId":"661fbd42-9fcb-4d47-8a74-7a23d161d57b","aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"moderate","rootCauseCategory":null,"rootCauseDetail":null,"affectedUnitsCount":102,"affectedUnitsBasis":"exact","remediationStatus":null,"regulatoryAction":"recall_ordered","regulatoryBody":"FDA","propertyDamageEstimateUsd":null,"damageEstimateBasis":null,"bodilyInjurySeverity":null,"fatalityCount":null,"lossCostClass":null,"sourceQualityTier":2,"createdAt":"2026-06-27T09:38:44.610Z","updatedAt":"2026-06-27T09:38:44.610Z","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-restoris-mck-baseplate-mislabel-recall-2023","url":"https://registry.deploy.report/incidents/stryker-mako-restoris-mck-baseplate-mislabel-recall-2023","headline":"Stryker recalls Mako Restoris MCK tibial baseplate trials over incorrect size laser marking","description":"Certain lots of the Mako Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials, used in robotic partial knee arthroplasty, carried incorrect size laser marking, creating a wrong-size component risk. Source: FDA Class 2 device recall Z-1386-2023 (102 units in commerce), accessdata.fda.gov.","identifier":"1ad4d4b8-1b96-4979-b7b4-840e4b0bc0cf","datePublished":"2023-03-10T00:00:00.000Z","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":[]}}}