{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "219208", "product_res_number": "Z-1997-2026", "event_date_initiated": "2026-03-25", "event_date_posted": "2026-04-29", "recall_status": "Open, Classified", "res_event_number": "98608", "product_code": "JDZ", "product_description": "Heraeus, PALAMIX uno. Material Number: 66057893.", "code_info": "Material Number: 66057893;\nUDI-DI: 04260102133587;\nBatch: all batches with numbers below 223060;", "firm_fei_number": "3006406161", "recalling_firm": "Heraeus Medical GmbH (Dental Division)", "address_1": "Philipp-Reis-Str. 8 8 philipp-reis-str.", "city": "Wehrheim", "country": "Germany", "reason_for_recall": "Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months).", "root_cause_description": "Under Investigation by firm", "action": "On 03/25/2026 Field Safety Notice letters were sent to customers.\nActions to be taken:\n1.\tRead this Field Safety Notice and ensure that all relevant hospital departments are informed about its content. \n2.\tPlease complete the attached customer reply form and send it to hm.fsca.medical@heraeus.com within five (5) calendar days. This form must be returned even if you no longer use the device.\n3.\tKeep a copy of the attached customer reply form with your records in the event of a compliance audit of your facility.", "product_quantity": "51,771 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Aland Islands, Algeria, Australia, Austria, Belgium, Brazil , Chile, China, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Kosovo, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Netherlands, Nigeria, Norway, Peru, Philippines, Poland, Portugal, Puerto Rico, Rep. of Korea, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom, Uruguay, Utd.Arab Emir.;", "openfda": { "k_number": [ "K934253", "K854077", "K760636", "K760617", "K792186", "K780857", "K853310", "K843219", "K861086", "K851205", "K892937", "K925025", "K912190" ], "registration_number": [ "3015225571", "3002808022", "3013186738", "3013557562", "3002558847", "3015831087", "3017910185", "1820334", "3005012805", "3012494290", "3006535925", "2649614", "3008788129", "3009475067", "3015542154", "3008388427", "1030489", "3038613790", "3036756245", "3014620201", "2648623", "3004142400", "3009599228", "3024088964", "2086043", "3014326245", "3004638532", "1417485", "3004046477", "9616671", "3005941719", "3006636962", "2648666", "1058584", "3000931034", "9616662", "3010536692", "1020279", "3015967359", "3042205143", "3006950086", "3011683674", "1215305", "3003169405", "3007997036", "3033589330", "1644312", "3002907620", "3009732568", "1822565", "3027234828", "2183301", "3027518990", "9614841", "3003477135", "3010178296", "1526350", "3015309643", "3015219237", "3035366890", "3003542872", "3006552587", "3006406161", "2530154", "1724474", "3005562917", "3010147274", "1721504", "3020163307", "1424263", "3008110533", "1450662", "3033509898", "3038503932", "3015207155", "9613350", "3007699035", "3025603301", "3014683120", "3007255375", "1526534", "3008114965", "3008583793", "1818910", "1423662", "3030733800", "9617616", "1526711", "3009125070", "3043648115", "9617155", "3011210208", "9615788", "3018242561", "3008812560", "9615014", "1928237", "9610921", "3008328679", "3002806603", "9615399", "3012497308", "3033536319", "3011944170", "3002807315", "3010303097", "3012536737", "3005176727", "3030446844", "3008770707", "2437780", "1417592", "3004734264", "3018094310", "3038718579", "3004111573", "8043792", "1649518", "3016678045", "1721676", "3010898856", "3015173212", "3012725451", "1825034", "3009504230", "3006847937", "3030412764", "1526439", "3003120897", "3008132398", "3002807295", "3005180920", "3009170227", "1123169", "3007366790" ], "fei_number": [ "3015225571", "3002808022", "3002808402", "3013186738", "3013557562", "3002558847", "3015831087", "3017910185", "1820334", "3005012805", "3012494290", "3006535925", "2649614", "3008788129", "3009475067", "3015542154", "3008388427", "3038613790", "3036756245", "3014620201", "2648623", "3004142400", "3003272754", "3009599228", "3024088964", "1000123143", "3014326245", "3004638532", "1417485", "3004046477", "3002807111", "3006636962", "2648666", "3000931034", "3010536692", "3005233524", "1020279", "3015967359", "3042205143", "1000307073", "3006950086", "3011683674", "1215305", "3003169405", "3007997036", "3033589330", "3003015552", "1000117748", "3002807091", "3000335778", "3002907620", "3009732568", "3027234828", "2183301", "3002574147", "3027518990", "3003477135", "3003094851", "1526350", "3015309643", "1000220733", "3015219237", "1000477302", "3035366890", "3003542872", "3006552587", "3006406161", "3005562917", "3010147274", "1721504", "3020163307", "3008110533", "1450662", "3033509898", "3038503932", "3003854593", "3015207155", "1000219637", "3007699035", "3025603301", "3014683120", "3007255375", "1526534", "3008114965", "3008583793", "1818910", "3030733800", "1526711", "3002854251", "3009125070", "3000719964", "3043648115", "3011210208", "3001236277", "3018242561", "3008812560", "1928237", "3008328679", "3002806603", "3033536319", "3012497308", "3011944170", "3002807315", "3010303097", "3012536737", "3005176727", "3030446844", "3008770707", "1417592", "3004734264", "3002806724", "3018094310", "3038718579", "3000215273", "3004111573", "3005568854", "1000345108", "3002808269", "3016678045", "1721676", "3010898856", "3015173212", "3012725451", "3001746544", "3009504230", "1825034", "3030412764", "3006847937", "3003110073", "1526439", "3003120897", "3002807295", "3005180920", "3009170227", "3007282753" ], "device_name": "Mixer, Cement, For Clinical Use", "medical_specialty_description": "Orthopedic", "regulation_number": "888.4210", "device_class": "1" } } ] }