{"recall":{"id":"fda-device-99692","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Onkos Surgical, Inc. recalls 2 products","firm":"Onkos Surgical, Inc.","date":"2026-07-24","reported":"2026-10-14","status":"Ongoing","classification":"Class II","products":[{"name":"Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M","code":"UDI: B278PVACREC04M0-Lot# C26-0346; Case# C26-0346,","quantity":"1 implant","number":"Z-0090-2027","classification":"Class II"},{"name":"Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M","code":"UDI: B278PVACREC04M0-Lot #C26-0371; Case# C26-0371","quantity":"1 implant","number":"Z-0091-2027","classification":"Class II"}],"reason":"Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the states of North Carolina, and California.","nationwide":true,"states":[],"units":"1 implant; 1 implant","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=99692","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"fe9e2f21adedf9e1","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=99692","record":[{"status":"Ongoing","city":"Parsippany","state":"NJ","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99692","recalling_firm":"Onkos Surgical, Inc.","address_1":"77 E Halsey Rd","address_2":"N/A","postal_code":"07054-3714","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"US Nationwide distribution in the states of North Carolina, and California.","recall_number":"Z-0090-2027","product_description":"Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left  REF PV-ACREC-04M","product_quantity":"1 implant","reason_for_recall":"Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.","recall_initiation_date":"20260724","center_classification_date":"20261006","report_date":"20261014","code_info":"UDI: B278PVACREC04M0-Lot# C26-0346; Case# C26-0346,"},{"status":"Ongoing","city":"Parsippany","state":"NJ","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99692","recalling_firm":"Onkos Surgical, Inc.","address_1":"77 E Halsey Rd","address_2":"N/A","postal_code":"07054-3714","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"US Nationwide distribution in the states of North Carolina, and California.","recall_number":"Z-0091-2027","product_description":"Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left  REF PV-ACREC-04M","product_quantity":"1 implant","reason_for_recall":"Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.","recall_initiation_date":"20260724","center_classification_date":"20261006","report_date":"20261014","code_info":"UDI: B278PVACREC04M0-Lot #C26-0371; Case# C26-0371"}]}}