{ "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": "197038", "product_res_number": "Z-0737-2023", "event_date_initiated": "2022-11-07", "event_date_posted": "2022-12-20", "recall_status": "Open, Classified", "res_event_number": "91147", "product_code": "LOD", "k_numbers": [ "K014199" ], "product_description": "Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic\n\t\nCatalog Number:6197-1-001", "code_info": "UDI# P/N 6197-1-001 (01)07613327128741 (17)230331(10)lot#\nGTIN: 07613327128741-Instructions for Use (IFU) received with product: 0700-7-012 (IFU Radiopaque Bone Cement)\n\nAll lots manufactured under Rev AB, which with expiration date on/after October 28, 2021", "firm_fei_number": "3003070421", "recalling_firm": "Howmedica Osteonics Corp.", "address_1": "325 Corporate Dr", "city": "Mahwah", "state": "NJ", "postal_code": "07430-2006", "additional_info_contact": "Loriann Russo\n201-831-5000", "reason_for_recall": "Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Although the Turkish translation is missing, all content within the IFUs is accurate.", "root_cause_description": "Under Investigation by firm", "action": "Update 12/15/22: An UPDATED Urgent Medical Device Correction PFA 3140774 was issued to impacted customers in Turkey only on December 15, 2022. Letter states:\n1.\tPlease inform users of this UPDATE Urgent Medical Device Correction and forward this notice to all individuals who need to be made aware.\n2.\tGo to link https://ifu.stryker.com/ and follow instructions for Figures 1 and 2 for the electronic version of the Turkish translated Instructions for Use for affected product outlined in Table 1.\n3.\tComplete and sign the enclosed UPDATE Urgent Medical Device Correction Business Reply Form.\nPotential Harm:\nThere are no identified harms associated with this issue which would lead to any known adverse health consequences.\n\nPlease assist us in meeting our regulatory obligation by emailing back the attached UPDATE Urgent Medical Device Correction Business Reply Form within 5 days. A response is required, even though you may not have any physical inventory on site. \nplease contact Customer Service at (888)-756-7846. For questions pertaining to the recall, email SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com.\n____________________________________________________________________________\nStryker issued Urgent Medical Device Correction PFA 3140774 to customers in Turkey only via Stryker sales representatives on Nov. 16, 2022. Letter states reason for recall and action to take:\n\n1.\tPlease inform users of this Urgent Medical Device Correction and forward this notice to all individuals who need to be made aware.\n2.\tGo to link https://ifu.stryker.com/ and follow instructions for Figures 1 and 2 for the electronic version of the Turkish translated Instructions for Use for affected product outlined in Table 1.\n3.\tComplete and sign the enclosed Urgent Medical Device Correction Business Reply Form.", "product_quantity": "20 units", "distribution_pattern": "International distribution in the country of Turkey.", "openfda": { "k_number": [ "K002652", "K021499", "K150408", "K001160", "K023012", "K142157", "K043403", "K192394", "K210607", "K123225", "K033563", "K143100", "K153737", "K202475", "K993836", "K091608", "K092150", "K143134", "K051532", "K030902", "K021715", "K033509", "K193061", "K211163", "K022688", "K081155", "K250760", "K182260", "K000943", "K053445", "K231556", "K092773", "K031673", "K051496", "K254107", "K033382", "K033596", "K172408", "K050854", "K213812", "K053003", "K170802", "K192379", "K193059", "K171540", "K050085", "K181282", "K030903", "K010586", "K150119", "K062553", "K014199", "K070015", "K023103", "K030904", "K212729", "K030086", "K032945", "K022251", "K050855", "K053198", "K123081", "K031430", "K241674", "K210120", "K190766", "K210125", "K202458", "K013755", "K211869", "K173494", "K041656" ], "pma_number": [ "P810020", "N17003", "N17755", "P970010", "N18466", "N17113", "N17004", "P960001" ], "registration_number": [ "3006406161", "9617616", "3010097171", "8030965", "3021566676", "3003678543", "9615014", "3013055499", "1644408", "3009417901", "3015542154", "3006950086", "2249697", "1825034", "3016678045", "2648623", "9616662", "3002807314", "8043792", "9612420", "2649614", "9610921", "9615788", "3017155536", "3013186738", "9610726", "3010537287", "9681465", "3015309643", "3008328679", "2031093", "1649518", "3008868758", "3014302784", "3006946279", "3008812560", "3040335671", "3005941719", "3002808022", "3009685086", "3002907620", "3006524618", "3011683674", "3020163307", "1721504", "3008132398", "3004464325", "3021638889", "3013546462", "9616671", "3000270450", "3005180920", "3012502601", "9614841", "1818910", "3015399803", "3007663067", "3033589330", "3012536737", "3006849754", "2648666", "3010536692", "3014003062", "3010132111", "3010898856", "3008110533", "3015225571", "1123169", "3013176080", "3034676720", "3035366890", "1000461041", "3015967359", "3002806603", "3010162973", "1526439", "2953359", "3015207155", "3015516266", "3015219237", "3004638532" ], "fei_number": [ "3006406161", "3010097171", "3021566676", "3003678543", "3013055499", "3009417901", "3002808402", "3015542154", "3006950086", "1825034", "3016678045", "3002854251", "2648623", "3002807314", "3002806724", "2649614", "3002807111", "3002807172", "3002807041", "3017155536", "3001236277", "3013186738", "3010537287", "3001236549", "3002807305", "3015309643", "3008328679", "3000215205", "3008868758", "3014302784", "3006946279", "3008812560", "3040335671", "3002808269", "3002808022", "1000116912", "3009685086", "3003272754", "3002907620", "3010813691", "3011683674", "3020163307", "1721504", "3004464325", "3002807091", "3005568854", "3021638889", "3013546462", "3000270450", "3005180920", "3012502601", "3000335778", "1818910", "1000123143", "3015399803", "3007663067", "3033589330", "3012536737", "3006849754", "2648666", "3010536692", "3014003062", "3010132111", "3010898856", "3008110533", "3015225571", "3002807156", "3003854593", "3002807113", "3013176080", "3034676720", "3035366890", "1000461041", "3015967359", "3003070421", "3002806603", "1526439", "3015207155", "3015516266", "3015219237", "3004638532" ], "device_name": "Bone Cement", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3027", "device_class": "2" } } ] }