{"id":"c08e6b1f-f559-40f6-bd97-39c7fc610ef9","slug":"fda-recall-rosa-one-brain-2021","filingNumber":null,"filingType":"fda_recall","jurisdiction":"us_fda","applicantCompanyId":"bf360924-7c7c-4b17-8fcf-8abf5950c0ff","filingDate":"2021-09-22T12:00:00.000Z","decisionDate":"2021-10-29T12:00:00.000Z","status":"recalled","clearanceScope":"Class I recall of the Zimmer Biomet ROSA ONE Brain 3.1 where software could drive the arm along an unintended trajectory; 2021.","sources":[{"url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm","title":"FDA Medical Device Recall - ROSA ONE Brain 3.1 (2021, Class I)","sourceName":"FDA Recall Database (primary)"}],"verificationPosture":"verified","capFlagNotes":null,"relatedIncidentId":"186fb155-6c2e-4812-907c-fd241200cad9","reviewStatus":"reviewed","deprecatedAt":null,"deprecationReason":null,"createdAt":"2026-06-04T23:17:17.303Z","updatedAt":"2026-06-05T15:35:55.071Z","applicantCompany":{"id":"bf360924-7c7c-4b17-8fcf-8abf5950c0ff","slug":"zimmer-biomet","name":"Zimmer Biomet"},"modelLinks":[{"id":"24381db1-8040-48ec-8d80-12f28c81d2da","modelId":"deb70c72-adc4-4912-b3f3-cddee712e118","regulatoryFilingId":"c08e6b1f-f559-40f6-bd97-39c7fc610ef9","createdAt":"2026-06-04T23:17:17.456Z","model":{"slug":"zimmer-biomet-rosa","modelName":"ROSA"}}]}