{"recall":{"id":"fda-device-99026","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"United Orthopedic Corp. recalls 4 products","firm":"United Orthopedic Corp.","date":"2026-05-20","reported":"2026-08-12","status":"Ongoing","classification":"Class II","products":[{"name":"Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/A","code":"Product Number; UDI-DI Code; Lot Code: Product Number 9323-5511; UDI-DI 04719886906929; Lot number 25FB54 Product Number 9323-5512; UDI-DI 04719886906936; Lot number 25FB55 Product Number 9323-5513; UDI-DI 04719886906943; Lot number 25FB56 Product Number 9323-5514; UDI-DI 04719886906950; Lot number 25FB57 Product Number 9323-5515; UDI-DI 04719886906967; Lot number 25FB58 Product Number 9323-5516; UDI-DI 04719886906424; Lot number 25FB59 Product Number 9323-5521; UDI-DI 04719886906974; Lot number 25FB29 Product Number 9323-5522; UDI-DI 04719886906981; Lot number 25FB30 Product Number 9323-5523; UDI-DI 04719886906998; Lot number 25FB31 Product Number 9323-5524; UDI-DI 04719886907001; Lot number 25FB32 Product Number 9323-5525; UDI-DI 04719886907018; Lot number 25FB33 Product Number 9323-5526; UDI-DI 04719886907025; Lot number 25FB34","quantity":"2","number":"Z-2883-2026","classification":"Class II"},{"name":"Brand Name: USTAR II Knee System Product Name: Hinge Box Trial, L, #1-6 and Hinge Box Trial, R, #1-6 Model/Catalog Number: 9325-5711 thru 9325-5716 and 9325-5721 thru 9325-5726 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/A","code":"Product Number; UDI-DI Code; Lot Code: Product number 9325-5711; UDI-DI 04719886907032; Lot number 25FB41 Product number 9325-5712; UDI-DI 04719886907049; Lot number 25FB42 Product number 9325-5713; UDI-DI 04719886907056; Lot number 25FB43 Product number 9325-5714; UDI-DI 04719886907063; Lot number 25FB44 Product number 9325-5715; UDI-DI 04719886907070; Lot number 25FB45 Product number 9325-5716; UDI-DI 04719886907087; Lot number 25FB46 Product number 9325-5721; UDI-DI 04719886907094; Lot number 25FB35 Product number 9325-5722; UDI-DI 04719886907100; Lot number 25FB36 Product number 9325-5723; UDI-DI 04719886907117; Lot number 25FB37 Product number 9325-5724; UDI-DI 04719886907124; Lot number 25FB38 Product number 9325-5725; UDI-DI 04719886907131; Lot number 25FB39 Product number 9325-5726; UDI-DI 04719886907148; Lot number 25FB40","quantity":"2","number":"Z-2884-2026","classification":"Class II"},{"name":"Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No","code":"Product Number; UDI-DI Code; Lot Code: Product number 9323-5333; UDI-DI 04719886908084; Lot number 25FB50 Product number 9323-5334; UDI-DI 04719886908091; Lot number 25FB51","quantity":"2","number":"Z-2885-2026","classification":"Class II"},{"name":"Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus offset adaptor, 2mm, 4mm, 6mm, right Model/Catalog Number: 9323-5335, 9323-5337, 9323-5339 and 9323-5336, 9323-5338, 9323-5340 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No","code":"Product Number; UDI-DI Code; Lot Code: Product number 9323-5335; UDI-DI 04719886906554; Lot number 25FB64 Product number 9323-5337; UDI-DI 04719886906578; Lot number 25FB48 Product number 9323-5339; UDI-DI 04719886906592; Lot number 25FB52 Product number 9323-5336; UDI-DI 04719886906561; Lot number 25FB65 Product number 9323-5338; UDI-DI 04719886906585; Lot number 25FB49 Product number 9323-5340; UDI-DI 04719886906608; Lot number 25FB53","quantity":"2","number":"Z-2886-2026","classification":"Class II"}],"reason":"Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.","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":"2; 2; 2; 2","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=99026","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"d1eb088f51ff6b02","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=99026","record":[{"status":"Ongoing","city":"Kaohsiung","state":"","country":"Taiwan","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99026","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-2883-2026","product_description":"Brand Name: U2 Total Knee System  Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6  Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526  Software Version: N/A  Product Description: Knee femur prosthesis trial, reusable  Component: No, N/A","product_quantity":"2","reason_for_recall":"Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.","recall_initiation_date":"20260520","center_classification_date":"20260805","report_date":"20260812","code_info":"Product Number; UDI-DI Code; Lot Code: Product Number 9323-5511; UDI-DI 04719886906929; Lot number 25FB54 Product Number 9323-5512; UDI-DI 04719886906936; Lot number 25FB55 Product Number 9323-5513; UDI-DI 04719886906943; Lot number 25FB56 Product Number 9323-5514; UDI-DI 04719886906950; Lot number 25FB57 Product Number 9323-5515; UDI-DI 04719886906967; Lot number 25FB58 Product Number 9323-5516; UDI-DI 04719886906424; Lot number 25FB59 Product Number 9323-5521; UDI-DI 04719886906974; Lot number 25FB29 Product Number 9323-5522; UDI-DI 04719886906981; Lot number 25FB30 Product Number 9323-5523; UDI-DI 04719886906998; Lot number 25FB31 Product Number 9323-5524; UDI-DI 04719886907001; Lot number 25FB32 Product Number 9323-5525; UDI-DI 04719886907018; Lot number 25FB33 Product Number 9323-5526; UDI-DI 04719886907025; Lot number 25FB34","more_code_info":""},{"status":"Ongoing","city":"Kaohsiung","state":"","country":"Taiwan","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99026","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-2884-2026","product_description":"Brand Name: USTAR II Knee System  Product Name: Hinge Box Trial, L, #1-6 and Hinge Box Trial, R, #1-6  Model/Catalog Number: 9325-5711 thru 9325-5716 and 9325-5721 thru 9325-5726  Software Version: N/A  Product Description: Knee femur prosthesis trial, reusable  Component: No, N/A","product_quantity":"2","reason_for_recall":"Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.","recall_initiation_date":"20260520","center_classification_date":"20260805","report_date":"20260812","code_info":"Product Number; UDI-DI Code; Lot Code:  Product number 9325-5711; UDI-DI 04719886907032; Lot number 25FB41 Product number 9325-5712; UDI-DI 04719886907049; Lot number 25FB42 Product number 9325-5713; UDI-DI 04719886907056; Lot number 25FB43 Product number 9325-5714; UDI-DI 04719886907063; Lot number 25FB44 Product number 9325-5715; UDI-DI 04719886907070; Lot number 25FB45 Product number 9325-5716; UDI-DI 04719886907087; Lot number 25FB46 Product number 9325-5721; UDI-DI 04719886907094; Lot number 25FB35 Product number 9325-5722; UDI-DI 04719886907100; Lot number 25FB36 Product number 9325-5723; UDI-DI 04719886907117; Lot number 25FB37 Product number 9325-5724; UDI-DI 04719886907124; Lot number 25FB38 Product number 9325-5725; UDI-DI 04719886907131; Lot number 25FB39 Product number 9325-5726; UDI-DI 04719886907148; Lot number 25FB40","more_code_info":""},{"status":"Ongoing","city":"Kaohsiung","state":"","country":"Taiwan","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99026","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-2885-2026","product_description":"Brand Name: U2 Total Knee System  Product Name: Femoral valgus adaptor, left and right  Model/Catalog Number: 9323-5333 and 9323-5334  Software Version: N/A  Product Description: Manual Orthopedic Surgical Instrument  Component: No","product_quantity":"2","reason_for_recall":"Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.","recall_initiation_date":"20260520","center_classification_date":"20260805","report_date":"20260812","code_info":"Product Number; UDI-DI Code; Lot Code: Product number 9323-5333; UDI-DI 04719886908084; Lot number 25FB50 Product number 9323-5334; UDI-DI 04719886908091; Lot number 25FB51","more_code_info":""},{"status":"Ongoing","city":"Kaohsiung","state":"","country":"Taiwan","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99026","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-2886-2026","product_description":"Brand Name: U2 Total Knee System  Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus offset adaptor, 2mm, 4mm, 6mm, right  Model/Catalog Number: 9323-5335, 9323-5337, 9323-5339 and 9323-5336, 9323-5338, 9323-5340  Software Version: N/A  Product Description: Manual Orthopedic Surgical Instrument  Component: No","product_quantity":"2","reason_for_recall":"Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.","recall_initiation_date":"20260520","center_classification_date":"20260805","report_date":"20260812","code_info":"Product Number; UDI-DI Code; Lot Code: Product number 9323-5335; UDI-DI 04719886906554; Lot number 25FB64 Product number 9323-5337; UDI-DI 04719886906578; Lot number 25FB48 Product number 9323-5339; UDI-DI 04719886906592; Lot number 25FB52 Product number 9323-5336; UDI-DI 04719886906561; Lot number 25FB65 Product number 9323-5338; UDI-DI 04719886906585; Lot number 25FB49 Product number 9323-5340; UDI-DI 04719886906608; Lot number 25FB53","more_code_info":""}]}}