{"id":"1a04a6d9-fb59-444e-92d8-e01f77c618e3","slug":"zimmer-rosa-258-tool-orientation-change-recall-2018","kind":"recall","headline":"Zimmer Biomet recalls ROSA Surgical Device 2.5.8 over software changing final tool orientation without command","summary":"Zimmer Biomet recalled the ROSA Surgical Device 2.5.8 because the software could change the final tool orientation for the command position without an operator command. 64 units. Source: FDA Class 2 device recall Z-0115-2018, openFDA enforcement / accessdata.fda.gov.","occurredAt":"2016-04-08T00:00:00.000Z","reviewStatus":"unreviewed","modelId":null,"deploymentId":null,"companyId":"bf360924-7c7c-4b17-8fcf-8abf5950c0ff","aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"serious","rootCauseCategory":null,"rootCauseDetail":null,"affectedUnitsCount":64,"affectedUnitsBasis":"exact","remediationStatus":null,"regulatoryAction":"recall_ordered","regulatoryBody":"FDA","propertyDamageEstimateUsd":null,"damageEstimateBasis":null,"bodilyInjurySeverity":null,"fatalityCount":null,"lossCostClass":null,"sourceQualityTier":2,"createdAt":"2026-06-27T11:10:33.227Z","updatedAt":"2026-06-27T11:10:33.227Z","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":[],"responses":[],"statusEvents":[],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/zimmer-rosa-258-tool-orientation-change-recall-2018","url":"https://registry.deploy.report/incidents/zimmer-rosa-258-tool-orientation-change-recall-2018","headline":"Zimmer Biomet recalls ROSA Surgical Device 2.5.8 over software changing final tool orientation without command","description":"Zimmer Biomet recalled the ROSA Surgical Device 2.5.8 because the software could change the final tool orientation for the command position without an operator command. 64 units. Source: FDA Class 2 device recall Z-0115-2018, openFDA enforcement / accessdata.fda.gov.","identifier":"1a04a6d9-fb59-444e-92d8-e01f77c618e3","datePublished":"2016-04-08T00:00:00.000Z","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":[]}}}