{"id":"9221069c-05d7-4ab9-bcc1-f8c09235f463","slug":"stryker-mako-mics-handpiece-characterization-recall-2025","kind":"recall","headline":"Stryker recalls Mako MICS Handpiece (2024) over a characterization error that can cause off-plan bone cuts","summary":"Stryker recalled the Mako Integrated Cutting System (MICS) Handpiece over a saw-blade characterization error that could cause bone-preparation discrepancies. Distinct from the 2020 MICS checkpoint-verification recall already recorded. 897 units. Source: FDA Class 2 device recall Z-0044-2025, accessdata.fda.gov / openFDA enforcement.","occurredAt":"2024-08-07T00:00:00.000Z","reviewStatus":"unreviewed","modelId":null,"deploymentId":null,"companyId":"661fbd42-9fcb-4d47-8a74-7a23d161d57b","aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"serious","rootCauseCategory":null,"rootCauseDetail":null,"affectedUnitsCount":897,"affectedUnitsBasis":"exact","remediationStatus":null,"regulatoryAction":"recall_ordered","regulatoryBody":"FDA","propertyDamageEstimateUsd":null,"damageEstimateBasis":null,"bodilyInjurySeverity":null,"fatalityCount":null,"lossCostClass":null,"sourceQualityTier":2,"createdAt":"2026-06-27T10:59:24.362Z","updatedAt":"2026-06-27T10:59:24.362Z","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-characterization-recall-2025","url":"https://registry.deploy.report/incidents/stryker-mako-mics-handpiece-characterization-recall-2025","headline":"Stryker recalls Mako MICS Handpiece (2024) over a characterization error that can cause off-plan bone cuts","description":"Stryker recalled the Mako Integrated Cutting System (MICS) Handpiece over a saw-blade characterization error that could cause bone-preparation discrepancies. Distinct from the 2020 MICS checkpoint-verification recall already recorded. 897 units. Source: FDA Class 2 device recall Z-0044-2025, accessdata.fda.gov / openFDA enforcement.","identifier":"9221069c-05d7-4ab9-bcc1-f8c09235f463","datePublished":"2024-08-07T00:00:00.000Z","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":[]}}}