{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 4 } }, "results": [ { "cfres_id": "217580", "product_res_number": "Z-1080-2026", "event_date_initiated": "2025-12-09", "event_date_posted": "2026-01-14", "recall_status": "Open, Classified", "res_event_number": "98078", "product_code": "LOD", "k_numbers": [ "K210607" ], "product_description": "Brand Name: PALACOS\nProduct Name: PALACOS R pro 40; PALACOS R pro 80\nModel/Catalog Number: 5081286; 5081287\nSoftware Version: N/A\nProduct Description: Radiopaque, 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).\nComponent: N/A", "code_info": "Lot Code: UDI-DI: 04260102136120; 04260102136151", "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": "increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of these influence factors can lead to unbreakable ampoules. If none or not all ampoules break, the product cannot be used on the patient since no or no appropriate cement dough is formed.", "root_cause_description": "Under Investigation by firm", "action": "On December 9, 2025 Urgent Field Safety Notice emails were sent to customers. Actions to be taken:\n1. Read this Field Safety Notice and ensure that all relevant hospital departments are informed about its content.\n2. Please 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. Keep a copy of the attached customer reply form with your records in the event of a compliance audit of your facility.\n4. Heraeus Medical GmbH is fully cooperating with regulatory authorities and is committed to resolving this issue efficiently. For further details regarding this field safety notice, please contact your Heraeus Medical sales representative or distributor.\nWe regret any inconvenience caused by this action and value your cooperation and commitment to patient safety.\nThis field safety notice was submitted to the FDA in context of the correction authority report.", "distribution_pattern": "International distribution in the countries of Aland Islands, Australia, Belgium, Denmark, Finland, Germany, Ireland, Italy, Liechtenstein, Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom.", "openfda": { "k_number": [ "K202458", "K043403", "K192394", "K171540", "K993836", "K142157", "K190766", "K002652", "K210607", "K022688", "K250760", "K021499", "K050854", "K010586", "K023103", "K030902", "K211163", "K022251", "K033382", "K143134", "K170802", "K192379", "K033563", "K202475", "K051532", "K023012", "K150119", "K092150", "K050085", "K001160", "K051496", "K091608", "K053003", "K182260", "K032945", "K193059", "K211869", "K030903", "K150408", "K081155", "K013755", "K143100", "K041656", "K062553", "K031673", "K033596", "K053198", "K173494", "K212729", "K153737", "K210125", "K123225", "K181282", "K123081", "K092773", "K030086", "K241674", "K030904", "K031430", "K050855", "K172408", "K000943", "K213812", "K193061", "K021715", "K033509", "K254107", "K070015", "K053445", "K231556", "K210120", "K014199" ], "pma_number": [ "N17113", "N17004", "N17755", "P810020", "P960001", "N18466", "N17003", "P970010" ], "registration_number": [ "3013546462", "9681465", "1721504", "3008328679", "3034676720", "9617616", "1000461041", "2649614", "3003678543", "3014302784", "3005941719", "3021566676", "1649518", "3002808022", "9610921", "8030965", "3013055499", "3002806603", "3002807314", "9615788", "3013186738", "3020163307", "3010132111", "9616662", "3006406161", "3004464325", "2249697", "3006524618", "3015225571", "3009417901", "3009685086", "3015516266", "3008110533", "3035366890", "9615014", "3015967359", "3011683674", "2953359", "9616671", "3006849754", "3015399803", "3006946279", "3033589330", "3000270450", "3015542154", "3016678045", "1123169", "3014003062", "3013176080", "3010162973", "3008812560", "1526439", "3005180920", "1644408", "3015309643", "9610726", "1825034", "1818910", "3006950086", "9612420", "3007663067", "9614841", "3012536737", "3002907620", "3040335671", "3004638532", "3015219237", "2648666", "2031093", "3017155536", "3008132398", "3010537287", "3008868758", "3015207155", "3010097171", "3010898856", "2648623", "3021638889", "3010536692", "3012502601", "8043792" ], "fei_number": [ "3013546462", "3002807113", "1721504", "3003854593", "3008328679", "3034676720", "3002807111", "3002806724", "1000461041", "2649614", "3003678543", "3014302784", "3000335778", "3021566676", "3002808022", "3013055499", "3003272754", "3002806603", "3001236277", "3000215205", "3002807314", "3013186738", "3020163307", "3010132111", "3002854251", "3006406161", "3004464325", "3002807305", "3015225571", "3009417901", "3009685086", "3015516266", "3008110533", "3010813691", "1000116912", "3035366890", "3002808269", "3015967359", "3011683674", "3001236549", "3006849754", "3015399803", "3006946279", "3033589330", "3000270450", "3015542154", "3002807156", "3016678045", "3014003062", "3013176080", "3002808402", "3008812560", "1526439", "3005180920", "3002807041", "3015309643", "1825034", "1818910", "3006950086", "3002807172", "3007663067", "3012536737", "3002907620", "3040335671", "3004638532", "3003070421", "3015219237", "2648666", "3017155536", "3005568854", "3010537287", "3008868758", "3015207155", "3010097171", "3010898856", "2648623", "1000123143", "3021638889", "3010536692", "3012502601", "3002807091" ], "device_name": "Bone Cement", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3027", "device_class": "2" } } ] }