{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 28 } }, "results": [ { "cfres_id": "159082", "product_res_number": "Z-0095-2018", "event_date_initiated": "2017-10-03", "event_date_created": "2017-11-16", "recall_status": "Terminated", "event_date_terminated": "2018-12-04", "res_event_number": "78297", "product_code": "HSX", "k_numbers": [ "K060670" ], "product_description": "iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR 501-UFLC, QTY 1, Rx ONLY, STERILE R, Arthrex, Inc., Naples, FL\nIndicated for use in uni-compartmental knee arthroplasty as a result of: 1. Moderately disabling joint disease of the knee resulting from painful osteoarthritis or posttraumatic arthritis. 2. Correction of functional deformity. 3. Revision of previous unsuccessful uni-compartmental knee replacement or other procedure. 4. As an alternative to tibial osteotomy in patients with uni-compartmental osteoarthritis.", "code_info": "batch 10123297", "firm_fei_number": "1220246", "recalling_firm": "Arthrex, Inc.", "address_1": "1370 Creekside Blvd", "city": "Naples", "state": "FL", "postal_code": "34108-1945", "reason_for_recall": "Arthrex part number AR-501-UFLC, size 3, batch 10123297, has the incorrect part number AR-501 UFRA, size 1 printed on the patient label inside the box.", "root_cause_description": "Process control", "action": "Arthrex sent an Urgent Medical Device Voluntary Recall letter on October 3, 2017. The letter requested the following:\n\"Immediately discontinue use of these devices. In order to receive\ncredit for the returned devices, please follow the steps below:\n1) Review this notification and ensure affected personnel are aware of the contents.\n2) Immediately identify and return all the indicated product/batch numbers you have in inventory. Call Arthrex Field Logistics Service at 1-866612-7899 for a returned goods authorization (RGA) and product return instructions. Email: FLS@Arthrex.com.\"\nCustomers with questions were instructed to call Product Surveillance at 866-267-9138 or by email to commplaints@arthrex.com.", "product_quantity": "20 units", "distribution_pattern": "Worldwide Distribution - US including SD, NV, NC, CA, MD, AZ, CA, LA, FL, PA, TX, NY, GA, and Internationally to GERMANY, POLAND", "openfda": { "k_number": [ "K121974", "K896856", "K914439", "K072368", "K200151", "K191150", "K220930", "K191325", "K771511", "K082172", "K080368", "K173970", "K072586", "K922824", "K903286", "K921232", "K261609", "K872735", "K992287", "K853020", "K113038", "K033769", "K081351", "K894068", "K803235", "K073175", "K831513", "K161060", "K073248", "K844355", "K063432", "K122529", "K251834", "K912735", "K033363", "K202207", "K213071", "K191211", "K251771", "K242746", "K853268", "K221292", "K861715", "K910083", "K926231", "K952068", "K800640", "K873970", "K060670", "K132640", "K161592", "K183029", "K162084", "K112301", "K061779", "K896648", "K792240", 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"medical_specialty_description": "Orthopedic", "regulation_number": "888.3520", "device_class": "2" } } ] }