{"id":"bd46942b-2550-42d5-9b3f-e27dedd33251","slug":"recall-2026-06-15-zimmer-biomet","kind":"recall","headline":"FDA Class I recall: Zimmer Biomet ROSA Brain 3.0 robotic surgery system software anomaly","summary":"FDA Class I recall for Zimmer Biomet ROSA Brain 3.0 robotic surgery system. Software issue can cause robotic arm to move to incorrect position during neurosurgery. 86 units affected in the US. Most serious recall type.","occurredAt":"2026-06-15T12:00:00.000Z","reviewStatus":"unreviewed","modelId":null,"deploymentId":null,"companyId":"bf360924-7c7c-4b17-8fcf-8abf5950c0ff","aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"catastrophic","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":null,"createdAt":"2026-07-03T04:15:04.459Z","updatedAt":"2026-07-03T04:15:04.459Z","model":null,"deployment":null,"company":{"id":"bf360924-7c7c-4b17-8fcf-8abf5950c0ff","name":"Zimmer Biomet","slug":"zimmer-biomet","description":"Zimmer Biomet, American orthopedic medical device company developing robotic surgery platforms ( Rosa) for joint replacement surgery.","status":"public (NYSE: ZBH)","founded":null,"hq":"Warsaw, IN","fundingTotal":null,"type":"both","reviewStatus":"reviewed","sources":[{"url":"https://investor.zimmerbiomet.com/news-and-events/news/2019/01-25-2019-140357749","title":"Zimmer Biomet receives FDA clearance for ROSA Knee System (Jan 25 2019; TKA)","sourceName":"Zimmer Biomet Investor Relations"},{"url":"https://investor.zimmerbiomet.com/news-and-events/news/2021/08-18-2021-133112714","title":"Zimmer Biomet receives FDA clearance for ROSA Hip System (Aug 18 2021; direct anterior THA)","sourceName":"Zimmer Biomet Investor Relations"},{"url":"https://www.prnewswire.com/news-releases/zimmer-biomet-receives-us-fda-clearance-for-enhanced-version-of-rosa-knee-robotic-technology-302615106.html","title":"ROSA Knee with OptimiZe FDA clearance (Nov 14 2025; US availability Q1 2026)","sourceName":"PR Newswire / Zimmer Biomet"}],"keyFacts":[{"label":"Product","value":"ROSA robotic surgical assistant (Knee/Hip/Brain/Shoulder); cross-domain ortho + neuro."},{"label":"Boundary","value":"AI-augmented surgeon-controlled assistance, NOT autonomous (autonomy is the separate Monogram line)."},{"label":"Stock listing","value":"NYSE: ZBH"},{"label":"ROSA origin","value":"ROSA originated at Medtech SA"},{"label":"Acquisition year","value":"Medtech SA acquired in 2016"}],"aliases":["Zimmer Biomet Holdings","Medtech SA"],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"createdAt":"2026-06-04T04:10:05.057Z","updatedAt":"2026-07-03T04:37:23.050Z"},"derived":{"status":"active"},"sources":[{"id":"4ca3c201-9cdb-4f1e-874f-58fb4ec0bbe8","incidentId":"bd46942b-2550-42d5-9b3f-e27dedd33251","url":"https://www.massdevice.com/fda-puts-class-1-label-on-zimmer-biomet-rosa-robotic-arm-recall/","label":null,"publishedAt":null,"notes":null,"title":"FDA puts Class I label on Zimmer Biomet's Rosa Brain robot recall","sourceName":"MassDevice","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-03T04:15:04.620Z","updatedAt":"2026-07-03T04:15:04.620Z"}],"responses":[],"statusEvents":[{"id":"2c301428-40ec-46cb-b1c9-e4d1f6cea6ab","incidentId":"bd46942b-2550-42d5-9b3f-e27dedd33251","status":"active","reason":null,"source":"agent:depth","effectiveAt":"2026-07-03T04:15:04.771Z","createdAt":"2026-07-03T04:15:04.772Z"}],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/recall-2026-06-15-zimmer-biomet","url":"https://registry.deploy.report/incidents/recall-2026-06-15-zimmer-biomet","headline":"FDA Class I recall: Zimmer Biomet ROSA Brain 3.0 robotic surgery system software anomaly","description":"FDA Class I recall for Zimmer Biomet ROSA Brain 3.0 robotic surgery system. Software issue can cause robotic arm to move to incorrect position during neurosurgery. 86 units affected in the US. Most serious recall type.","identifier":"bd46942b-2550-42d5-9b3f-e27dedd33251","datePublished":"2026-06-15T12:00:00.000Z","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":1,"primary_source_types":[]}}}