{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "169829", "product_res_number": "Z-0794-2019", "event_date_initiated": "2018-11-16", "event_date_created": "2019-02-02", "recall_status": "Terminated", "event_date_terminated": "2019-11-22", "res_event_number": "81782", "product_code": "HSD", "k_numbers": [ "K062861" ], "product_description": "Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW", "code_info": "170691", "firm_fei_number": "3002788818", "recalling_firm": "Ascension Orthopedics, Inc", "address_1": "8700 Cameron Rd Ste 100 8700 Cameron Rd", "address_2": "Ste 100", "city": "Austin", "state": "TX", "postal_code": "78754-3947", "additional_info_contact": "Dr. Patricai Kihn\n609-750-4220", "reason_for_recall": "The product was packaged with the Instructions for Use for a different product (Ascension First Choice DRUJ System Partial Ulnar Head Implant).", "root_cause_description": "Vendor change control", "action": "On 11/16/18, the recalling firm sent out an Urgent Voluntary Medical Device Correction letter via email to affected customers to notify them of the product issue. A second, updated letter was sent on 12/13/18.\n\nThe firm requests that all recipients please examine their inventory to determine if they have any MRH Radial Head Implants, catalog number, MRH-350-04-WW, from lot number, 170691.\n\nCustomers:\n\n- If you do have any MRH Radial Head Implants, catalog number, MRH-350-04-WW, from lot number, 170691 please discard the First Choice DRUJ System Partial Ulnar Head Implant instructions packaged with the product and use the attached correct IFU provided to you along with this communication letter.\n\nDistributors:\n- If you do have any unused MRH Radial Head Implants, catalog number, MRH-350-04-WW, from lot number, 170691 please return them to Integra.\n- We also kindly ask you to provide us the final customer list who may have the affected products. Integra will provide them the correct IFU.\n\nComplete the attached Acknowledgement Form and return the completed form by email or fax indicating receipt and review of this notification. Keep a copy of the form for your records.\n\nShould you have any questions regarding these instructions, please contact Customer Service\nMonday to Friday 8:00 AM 8:00 PM EST\nUSA: 1-800-654-2873: email: custsvcnj@integralife.com\nOutside USA: 1- 609-936-5400; email: INTERNATIONALCS@integralife.com", "distribution_pattern": "Distributed to accounts in MO. Foreign distribution to Korea and Thailand.", "openfda": { "k_number": [ "K911982", "K962289", "K023096", "K911902", "K062661", "K061454", "K051843", "K130759", "K012377", "K905577", "K062845", "K082715", "K031971", "K874643", "K873073", "K063081", "K121714", "K161620", "K010657", "K982886", "K003044", "K010664", "K173964", "K130635", "K992525", "K033516", "K061677", "K954559", "K073331", "K151527", "K003428", "K063578", "K911686", "K080990", "K191433", "K032126", "K111097", "K161782", "K112900", "K822771", "K032264", "K131298", "K791548", "K061862", "K873679", "K112983", "K950594", "K130675", "K193122", "K070963", "K233260", "K802123", "K800494", "K935593", "K040432", "K961260", "K992394", "K943908", "K072578", "K984202", "K142942", "K905580", "K010827", "K062861", "K001419", "K071064", "K040128", "K060535", "K221232", "K913282", "K011942" ], "registration_number": [ "1020279", "3009116370", "8010916", "3010041693", "3004983210", "2029275", "3011189525", "1822565", "3015806723", 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