{"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":"unreviewed","modelId":"b3a006a0-d844-4fb4-b4d9-dd6f148c0958","deploymentId":null,"companyId":"661fbd42-9fcb-4d47-8a74-7a23d161d57b","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,"createdAt":"2026-06-11T01:52:00.176Z","updatedAt":"2026-06-11T01:52:00.176Z","model":{"id":"b3a006a0-d844-4fb4-b4d9-dd6f148c0958","companyId":"661fbd42-9fcb-4d47-8a74-7a23d161d57b","modelName":"Mako","slug":"stryker-mako","description":"Mako (marketed as Mako SmartRobotics) is Stryker's surgeon-guided robotic-arm system for orthopedic joint replacement, recorded in the surgical form factor as the large-footprint, CT-based commercial-market-leader archetype of the orthopedic sub-cohort. It pairs CT-based three-dimensional pre-operative planning with intra-operative haptic boundary control, branded AccuStop, that physically constrains the saw or burr to the planned resection zone, and real-time optical bone tracking that keeps that boundary registered to the patient; the surgeon holds and guides the arm and makes every cut, so the system is AI-augmented surgeon-controlled assistance and not autonomous surgery, the same assistive class as Intuitive's da Vinci. Made by Stryker, listed on the New York Stock Exchange as SYK, founded in 1941 by Dr. Homer H. Stryker, incorporated in Michigan in 1946 and headquartered in Portage, Michigan, the platform entered Stryker through its roughly 1.65 billion dollar acquisition of MAKO Surgical at thirty dollars per share, announced September 25, 2013 and closed December 17, 2013, when MAKO's product was the RIO system cleared for partial knee and total hip. Its FDA-cleared scope has since broadened to partial and total knee, cementless total knee, total hip, a hip-revision feature, the Mako Spine System for non-cervical pedicle-screw placement cleared under 510(k) K241517 in May 2024, and the Mako Shoulder application for reverse shoulder arthroplasty cleared under 510(k) K242373 in November 2024. Per Stryker's FY2024 10-K the system is sold in more than forty-five countries with more than one million robotic Mako Total Knees and 1.5 million total Mako procedures performed cumulatively, and Stryker describes itself as one of four leading global competitors rather than asserting a specific market share; no installed-base system count appears in the 10-K, so any thousands-of-systems or market-share figure is aggregator-sourced and is not asserted here.","formFactor":"surgical","maturityStage":"commercial","lifecycleState":"active","supersededByModelId":null,"specs":{"notes":[{"label":"Corporate / acquisition","value":"Stryker (NYSE: SYK) founded 1941 by Dr. Homer H. Stryker, incorporated in Michigan 1946; principal offices Portage, Michigan (NOT Kalamazoo - the founding metro). Acquired MAKO Surgical for ~$1.65B ($30.00/share; announced Sep 25 2013, closed Dec 17 2013); MAKO's product was the RIO Robotic Arm Interactive Orthopedic System (then cleared for partial knee + total hip)."},{"label":"AI-as-primary boundary (the cohort's editorial point)","value":"AI-AUGMENTED, SURGEON-CONTROLLED assistance - NOT autonomous surgery. Software does CT planning, real-time bone tracking, and haptic boundary enforcement (stops the tool at the plan boundary); the surgeon guides the arm and makes all cuts. Same assistive class as Intuitive da Vinci; in-scope as a surgical robot."},{"label":"Verified scale (SEC, FY2024 10-K)","value":">1 million robotic Mako Total Knees and 1.5 million total Mako procedures performed globally (cumulative) across hips/knees; sold in 45+ countries. Stryker describes itself as 'one of four leading global competitors' (with Zimmer Biomet, J&J MedTech, Smith+Nephew) - it does NOT self-assert a market-share % in the 10-K."},{"label":"Cap-flag (aggregator drift)","value":"No installed-base system count appears in the FY2024 10-K - any 'thousands of systems' or specific market-share % is aggregator/analyst-sourced; do not assert. Spine + Shoulder 510(k)s ARE cleared (K241517 / K242373); 2025/2026 'coming' framing in trade coverage refers to commercial rollout, not regulatory status. The hip-revision 'first FDA-authorized revision feature' (Mar 2025) is trade-press, not SEC-verified."},{"label":"Sub-cohort triangle (orthopedic, within surgical)","value":"Large-footprint commercial-market-leader archetype with the broadest multi-procedure clearance (knee/hip/spine/shoulder). The orthopedic triangle: Mako (large-footprint, CT-based, broad scope) vs Smith+Nephew CORI (handheld, imageless, knee) vs Zimmer Biomet ROSA (mid-size, knee/hip/brain). Form-factor + procedure-scope + parent-company variance across three public (SEC-disclosed) makers."}],"specs":"Mako (Mako SmartRobotics): surgeon-guided robotic arm for orthopedic joint replacement. CT-based 3D pre-op planning + intra-op HAPTIC BOUNDARY CONTROL (AccuStop: physically constrains the saw/burr to the planned resection zone) + real-time optical bone tracking. The surgeon holds/guides the arm and makes every cut; the robot does not move or cut autonomously. Cleared procedures: partial/unicompartmental knee, total knee (Aug 2015), cementless total knee, total hip, a hip-revision feature, Mako Spine (510(k) K241517, May 2024; non-cervical pedicle-screw placement via the Q Guidance System), and Mako Shoulder 1.0 (510(k) K242373, Nov 2024; reverse shoulder arthroplasty). Sold in 45+ countries. Made by Stryker (NYSE: SYK).","formFactor":"surgical (robotic-arm-assisted orthopedic joint replacement; surgeon-controlled + AI-augmented, NOT autonomous; large-footprint CT-based)","fda_clearance":"510(k) K241517, 510(k) K242373","visualization":"CT-based three-dimensional pre-operative planning, real-time optical bone tracking","clearance_body":"FDA","procedure_types":"partial and total knee, cementless total knee, total hip, a hip-revision feature, non-cervical pedicle-screw placement, reverse shoulder arthroplasty"},"manufacturerSerial":null,"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"},{"url":"https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241517.pdf","title":"Mako Spine System 510(k) K241517 (decision May 29 2024; non-cervical pedicle-screw placement)","sourceName":"FDA 510(k) Database"},{"url":"https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94neurological-surgical-devices/OLO/K242373","title":"Mako Shoulder Application 1.0 510(k) K242373 (Nov 7 2024; reverse shoulder arthroplasty)","sourceName":"FDA 510(k)"},{"url":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12588732/","title":"Robotic-assisted TKA with Mako: systematic review and meta-analysis (2025; better medium-term function, more RCTs urged)","sourceName":"PubMed Central / Bone & Joint Open"},{"url":"https://www.stryker.com/us/en/joint-replacement/systems/Mako_SmartRobotics_Overview.html","title":"Mako SmartRobotics overview (CT-based planning + AccuStop haptic boundary + bone tracking)","sourceName":"Stryker (official)"}],"aliases":["Mako","Mako SmartRobotics","MAKO","Stryker Mako","RIO"],"collisionRisk":"low","reviewNote":null,"manufacturerTermForTeleop":null,"keyFacts":[{"label":"Autonomy level","value":"AI-augmented, surgeon-controlled assistance (not autonomous)"},{"label":"Form factor","value":"Large-footprint, CT-based robotic-arm system for orthopedic joint replacement"},{"label":"Acquisition price","value":"~$1.65 billion ($30.00 per share)"},{"label":"Countries sold in","value":"45+ countries"},{"label":"Cumulative procedures","value":">1 million Mako Total Knees and 1.5 million total Mako procedures performed globally"},{"label":"FDA clearance","value":"510(k) K241517 — Mako Spine System for non-cervical pedicle-screw placement, cleared May 2024"},{"label":"FDA clearance","value":"510(k) K242373 — Mako Shoulder application for reverse shoulder arthroplasty, cleared November 2024"}],"createdAt":"2026-06-04T04:09:26.181Z","updatedAt":"2026-06-29T03:16:43.644Z"},"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-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":"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":[]}}}