{"recall":{"id":"fda-device-99870","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Think Surgical, Inc. recalls Think Surgical Square Driver REF: 109126","firm":"Think Surgical, Inc.","date":"2026-08-20","reported":"2026-10-28","status":"Ongoing","classification":"Class II","products":[{"name":"Think Surgical Square Driver REF: 109126","code":"Lot: 25356/Primary DI: M9461091260","quantity":"15 units","number":"Z-0192-2027","classification":"Class II"}],"reason":"Robotic system square drive failed to meet design specifications potentially resulting in pin becoming stuck in square driver or the pin wobbling during drilling.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the states of NY and DE.","nationwide":true,"states":[],"units":"15 units","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99870","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"e4544b34fa76a08f","firstSeen":"2026-11-02T22:17:07.772Z","updatedAt":"2026-11-02T22:17:07.772Z","history":[]},"official":{"fetchedAt":"2026-11-02T22:17:07.772Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99870","record":[{"status":"Ongoing","city":"Fremont","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99870","recalling_firm":"Think Surgical, Inc.","address_1":"47201 Lakeview Blvd","address_2":"","postal_code":"94538-6530","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"US Nationwide distribution in the states of NY and DE.","recall_number":"Z-0192-2027","product_description":"Think Surgical Square Driver  REF: 109126","product_quantity":"15 units","reason_for_recall":"Robotic system square drive failed to meet design specifications potentially resulting in pin becoming stuck in square driver or the pin wobbling during drilling.","recall_initiation_date":"20260820","center_classification_date":"20261016","report_date":"20261028","code_info":"Lot: 25356/Primary DI: M9461091260","more_code_info":""}]}}