{"recall":{"id":"fda-device-99025","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"United Orthopedic Corp. recalls 2 products","firm":"United Orthopedic Corp.","date":"2026-03-19","reported":"2026-08-12","status":"Ongoing","classification":"Class II","products":[{"name":"Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and 4mm Model/Catalog Number: 9323-5310 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No, N/A","code":"Lot Code: Product Number 9323-5310; UDI-DI 04719886908060; Lot number 25FC58","quantity":"3","number":"Z-2897-2026","classification":"Class II"},{"name":"Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 2mm and 6mm Model/Catalog Number: 9323-5312 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No, N/A","code":"Lot Code: Product number 9323-5312; UDI-DI 04719886908077; Lot number 25FC64","quantity":"3","number":"Z-2898-2026","classification":"Class II"}],"reason":"Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the states of Texas and Michigan.","nationwide":true,"states":[],"units":"3; 3","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=99025","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"408d2b21644eb98a","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=99025","record":[{"status":"Ongoing","city":"Kaohsiung","state":"","country":"Taiwan","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99025","recalling_firm":"United Orthopedic Corp.","address_1":"No. 16 Luke 1st Rd.","address_2":"Luzhu Dist.","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of Texas and Michigan.","recall_number":"Z-2897-2026","product_description":"Brand Name: U2 Total Knee System  Product Name: Femoral offset bushing, 0mm and 4mm  Model/Catalog Number: 9323-5310  Software Version: N/A  Product Description: Manual Orthopedic Surgical Instrument  Component: No, N/A","product_quantity":"3","reason_for_recall":"Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.","recall_initiation_date":"20260319","center_classification_date":"20260806","report_date":"20260812","code_info":"Lot Code: Product Number 9323-5310; UDI-DI 04719886908060; Lot number 25FC58","more_code_info":""},{"status":"Ongoing","city":"Kaohsiung","state":"","country":"Taiwan","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99025","recalling_firm":"United Orthopedic Corp.","address_1":"No. 16 Luke 1st Rd.","address_2":"Luzhu Dist.","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of Texas and Michigan.","recall_number":"Z-2898-2026","product_description":"Brand Name: U2 Total Knee System  Product Name: Femoral offset bushing, 2mm and 6mm  Model/Catalog Number: 9323-5312  Software Version: N/A  Product Description: Manual Orthopedic Surgical Instrument  Component: No, N/A","product_quantity":"3","reason_for_recall":"Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.","recall_initiation_date":"20260319","center_classification_date":"20260806","report_date":"20260812","code_info":"Lot Code: Product number 9323-5312; UDI-DI 04719886908077; Lot number 25FC64","more_code_info":""}]}}