{"recall":{"id":"fda-device-99219","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Think Surgical, Inc. recalls TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking Array REF 109004 UDI-DI co","firm":"Think Surgical, Inc.","date":"2026-05-08","reported":"2026-07-15","status":"Ongoing","classification":"Class II","products":[{"name":"TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking Array REF 109004 UDI-DI code: M9461090040 TMINI Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components","code":"Model Number: 109003 UDI-DI code: M9461090030 Model Number: 109004 UDI-DI code: M9461090040","quantity":"360 devices","number":"Z-2716-2026","classification":"Class II"}],"reason":"Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"U.S. Nationwide distribution in the states of AZ, CA, DE, FL, IA, KS, LA, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OR, PA, TX, UT, VA, and WA.","nationwide":true,"states":[],"units":"360 devices","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=99219","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"03d7e3cdaabf6454","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","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=99219","record":[{"status":"Ongoing","city":"Fremont","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99219","recalling_firm":"Think Surgical, Inc.","address_1":"47201 Lakeview Blvd","address_2":"N/A","postal_code":"94538-6530","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"U.S. Nationwide distribution in the states of AZ, CA, DE, FL, IA, KS, LA, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OR, PA, TX, UT, VA, and WA.","recall_number":"Z-2716-2026","product_description":"TMINI Femur Tracking Array REF 109003  UDI-DI code: M9461090030    TMINI Tibia Tracking Array REF 109004  UDI-DI code: M9461090040    TMINI Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components","product_quantity":"360 devices","reason_for_recall":"Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.","recall_initiation_date":"20260508","center_classification_date":"20260709","report_date":"20260715","code_info":"Model Number: 109003 UDI-DI code: M9461090030   Model Number: 109004 UDI-DI code: M9461090040"}]}}