{ "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": "2026-09-28", "results": { "skip": 0, "limit": 1, "total": 4 } }, "results": [ { "cfres_id": "222253", "product_res_number": "Z-3301-2026", "event_date_initiated": "2026-08-20", "event_date_posted": "2026-09-25", "recall_status": "Open, Classified", "res_event_number": "99708", "product_code": "LOD", "k_numbers": [ "K210607" ], "product_description": "PALACOS R pro 40; PALACOS R pro 80. Model/Catalog Numbers: 5081286; 5081287.\r\n\r\nRadiopaque, poly (methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix).", "code_info": "UDI-DI: 04260102136120, 04260102136151. All Batch Numbers. All Lot Numbers.", "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": "Potential for monomer liquid leakage.", "root_cause_description": "Under Investigation by firm", "action": "Heraeus Medical notified consignees on about 08/20/2026 via emailed letter. Consignees were informed of the issue and risk and were instructed to read the Correction Letter carefully and ensure that all relevant hospital departments are made aware of its contents, ensure that suitable eye protection is worn whenever the system is being operated, and complete and return the provided reply form. If any leakage is observed, do not continue to use the product. Instead, discard it with additional precautions, such as wearing double gloves (e.g. nitrile rubber), in accordance with internal hospital procedures and local waste disposal guidelines. Additionally, consignees were instructed to keep a copy of the provided response form with your records in case your organization is subject to a compliance audit.", "product_quantity": "33,727 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Aland Islands, Australia, Austria, Belgium, Denmark, Finland, Germany, Greece, Ireland, Italy, Japan, Liechtenstein, Malta, Netherlands, New Zealand, Norway, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom.", "openfda": { "k_number": [ "K193061", "K030086", "K070015", "K210125", "K241674", "K030904", "K053003", "K190766", "K092150", "K022251", "K143134", "K173494", "K210607", "K023103", "K050085", "K143100", "K213812", "K250760", "K033563", "K030903", "K192379", "K050854", "K212729", "K013755", "K062553", "K993836", "K170802", "K231556", "K022688", "K053445", "K031673", "K123081", "K150408", "K193059", "K091608", "K182260", "K181282", "K171540", "K033596", "K033509", "K002652", "K092773", "K211869", "K142157", "K021715", "K202475", "K051496", "K000943", "K001160", "K030902", "K032945", "K023012", "K123225", "K210120", "K014199", "K150119", "K041656", "K172408", "K021499", "K211163", "K033382", "K051532", "K153737", "K202458", "K081155", "K043403", "K010586", "K050855", "K254107", "K053198", "K031430", "K192394" ], "pma_number": [ "N17004", "N17755", "N18466", "P810020", "N17113", "P970010", "P960001", "N17003" ], "registration_number": [ "3010537287", "3013176080", "3003678543", "3010097171", "9610921", "3006849754", "9617616", "2648623", "3010898856", "3015516266", "3014003062", "3008110533", "3015309643", "3021566676", "1526439", "3009685086", "3002808022", "1825034", "9610726", "3040335671", "9681465", "3000270450", "3015207155", "3004638532", "3005941719", "3035366890", "3014302784", "3033589330", "3015225571", "3015542154", "3009417901", "1644408", "1649518", "3012536737", "9612420", "3020163307", "1721504", "2249697", "3004464325", "3008812560", "3005180920", "3010162973", "3008328679", "9614841", "3008132398", "3002806603", "2031093", "9616662", "1000461041", "3002907620", "9615788", "3006950086", "3010132111", "3006524618", "2648666", "3013055499", "1123169", "3007663067", "3015399803", "3021638889", "8010379", "3013186738", "2953359", "8043792", "9615014", "8030965", "3011683674", "3002807314", "3012502601", "1818910", "2649614", "3015219237", "3006406161", "3010536692", "3013546462", "3008868758", "3006946279", "3016678045", "3017155536", "3015967359", "3034676720", "9616671" ], "fei_number": [ "3010537287", "3013176080", "3003678543", "3010097171", "3006849754", "3000215205", "3002807172", "2648623", "3010898856", "3015516266", "3014003062", "3002807113", "3008110533", "3015309643", "3021566676", "1526439", "3010813691", "3009685086", "3001236277", "3002808402", "3002808022", "1825034", "3040335671", "3003854593", "3000270450", "3015207155", "3004638532", "3035366890", "3014302784", "3033589330", "3015225571", "3015542154", "3003070421", "3009417901", "3002807041", "3012536737", "3020163307", "1721504", "3004464325", "3002806724", "3008812560", "3005180920", "3005568854", "3008328679", "3002807305", "3002807156", "3002807091", "3002806603", "1000461041", "3002907620", "3002808269", "3006950086", "3010132111", "3001236549", "3003272754", "1000116912", "2648666", "3002854251", "3013055499", "3007663067", "3000335778", "3015399803", "3021638889", "3013186738", "3011683674", "3002807314", "3012502601", "1818910", "2649614", "1000123143", "3015219237", "1000199976", "3006406161", "3002807111", "3010536692", "3013546462", "3008868758", "3006946279", "3016678045", "3017155536", "3015967359", "3034676720" ], "device_name": "Bone Cement", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3027", "device_class": "2" } } ] }