{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "176787", "product_res_number": "Z-0244-2020", "event_date_initiated": "2019-09-10", "event_date_created": "2019-10-30", "recall_status": "Terminated", "event_date_terminated": "2020-05-12", "res_event_number": "83942", "product_code": "JDQ", "k_numbers": [ "K181607" ], "product_description": "A&E Medical Thorecon Plating System Kits Model No. 94-1400-04. For fracture fixation or reconstruction of the sternum.", "code_info": "327705, 327706, 330587, 330588, 330753, 334396, 345417, 345418", "firm_fei_number": "2242056", "recalling_firm": "Alto Development Corp", "address_1": "5206 Asbury Rd", "city": "Wall Township", "state": "NJ", "postal_code": "07727-3609", "additional_info_contact": "Customer Service\n800-323-4035", "reason_for_recall": "Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensioner inoperable.", "root_cause_description": "Process control", "action": "On September 10, 2019, the firm distributed a letter to customers titled Product Recall: Action Required.\n\nThe letter informed customers of the potential tensioner failure. Customers were given two options:\n1. A&E will provide a supply of individually packaged, sterile tensioners to be kept on hand should a kit tensioner be found inoperable. Surgeons and Operating Room staff need to be alerted to this situation and the stock of additional tensioners readily available to them during surgery.\n2. For those customers who prefer to return their affected lots of Thorecon, A&E will provide a Returned Goods Authorization and replacement product (to be provided as soon as inventory is available).\n\nAny failed tensioners can be discarded.\n\nCustomers were asked to complete and return the acknowledgement form included with the mailing. \n\nShould you have any questions about the action or the product, please contact your A&E Sales Representative or our Customer Service at 800-323-4035.", "product_quantity": "209 total", "distribution_pattern": "Distributed to AL, CA, FL, GA, IL, LA, MO, OK, MS, NM, OK, SC, TX, UT, VT, WA, and WI.", "openfda": { "k_number": [ "K003951", "K953777", "K232986", "K875156", "K935481", "K010943", "K935646", "K973098", "K261271", "K102834", "K151848", "K081622", "K934557", "K110541", "K001254", "K984432", "K922142", "K120177", "K180582", "K932687", "K961569", "K232733", "K913735", "K934059", "K915581", "K961267", "K931246", "K103797", "K110039", "K151346", "K882890", "K161876", "K953818", "K151983", "K962162", "K151888", "K221795", "K971741", "K031508", "K121541", "K993286", "K920201", "K071271", "K091190", "K033816", "K982545", "K922952", "K143716", "K043252", "K230976", "K150889", "K220765", "K233949", "K150581", "K202016", "K211613", "K000694", "K842977", "K961283", "K023564", "K081205", "K903676", "K970084", "K101484", "K040199", "K874919", "K243344", "K960651", "K243905", "K942300", "K882967", "K201497", "K983976", "K993903", "K944529", "K951844", "K940729", "K063017", "K992616", "K925812", "K060009", "K181607", "K935950", "K914693", "K921480", "K924141", "K133785", "K181749", "K930015", "K932024", "K133354", "K926116", "K050041", "K912207", "K962132", "K231333", "K892411", "K193479", "K992891", "K934176", "K173910", "K173579", "K925447", "K950027", "K980690", "K031162", "K170206", "K914374", "K974016", "K880309", "K974020", "K910128", "K153242", "K030256", "K945294", "K112736", "K090686", "K923869", "K935592", "K850631", "K001709", "K972327", "K193468", "K110789", "K002110", "K915259", "K172975", "K130431", "K941213", "K934058" ], "registration_number": [ "3010331645", "3008812251", "2027148", "3017528621", "1220477", "3010163695", "3013055499", "1057946", "3018094310", "2242056", "3007304202", "3014302784", "3014004349", "3015542154", "3008974316", "3031240334", "3013014058", "1450662", "3010400367", "9610612", "3002579136", "3015869493", "3002807315", "3016050940", "3008559295", "3010173425", "1835296", "9613369", "3011302692", "3006498370", "1531174", "1526439", "3012447612", "3008110533", "3011295718", "2249697", "3015399803", "3002907620", "3033509898", "1720929", "1828464", "1824199", "3015806723", "3010191069", "3006017180", "1226544", "2032098", "3006217744", "3015974593", "3011683674", "3008951116", "3011230048", "3014262693", "3015882686", "3015207155", "1834331", "1833986", "3004635447", "1423662", "3010363503", "3009882675", "3009417901", "3010041499", "1043653", "1032347", "9610905", "3012329552", "3016438694", "3010097171", "1221053", "3021008900", "1030489", "3030412764", "3007675554", "8043792", "3015231789", "1058584", "3008868758", "9616062", "1834379", "3013756169", "3009973336", "3003761012", "3013011598", "3020704423", "3004153896", "1064858", "1526534", "3013176080", "3008793310", "1833824", "2183946", "3004464325", "3006801265", "3005180920", "2028632", "3010155648", "3014680795", "2133928", "3021226419", "3008556682", "1643817", "1220246", "9610726", "2032093", "3010220595", "1822565", "3009973505", "3015876273", "3015440604", "1047843", "3005061536", "3013302242", "3027404764", "1825034", "1424263", "3038503932", "2029275", "3016727307", "9616680", "3030517273", "3006395932", "3000270450", "2134285", "1020279", "3025141", "3007366790", "2249615", "8010257", "3004142400", "3008812560", "3003477135", "2953359", "3009971621", "8031020", "3009888740", "3025603301", "3036756245", "3016851379", "3003755939", "1828288", "3012883081", "1643264", "1824313", "1818910", "3035366890", "3008114965", "3043620689", "3006946276", "3004774118", "3006128100", "3034676720", "3019269298", "3004893332" ], "fei_number": [ "3010331645", "1000219637", "2027148", "3017528621", "1220477", "3003015552", "3010163695", "3013055499", "2242056", "3018094310", "1000139987", "3007304202", "3014302784", "3014004349", "3007282753", "3015542154", "3008974316", "3031240334", "3013014058", "1450662", "3010400367", "3002579136", "3015869493", "3002807315", "3016050940", "1000220733", "1000306431", "3008559295", "3002807464", "3002807172", "3006498370", "3011302692", "1526439", "3012447612", "3008110533", "3011295718", "3015399803", "3002907620", "3033509898", "1720929", "1828464", "1824199", "3015806723", "3010191069", "3006017180", "3000210784", "3006217744", "3002993297", "3015974593", "3011683674", "3008951116", "3011230048", "3014262693", "1000306303", "3015882686", "3015207155", "3004635447", "1000125025", "3010363503", "3009417901", "1043653", "3000215273", "1032347", "3012329552", "3016438694", "1000525271", "3010097171", "1221053", "3021008900", "3030412764", "3007675554", "3008397795", "3003070421", "3001049282", "3015231789", "3002808293", "3008868758", "3009256700", "3008647423", "1000116116", "3009973336", "3003761012", "3013011598", "3013756169", "3020704423", "3004153896", "1526534", "3003058119", "3013176080", "3008793310", "3004464325", "1000306340", "3006801265", "4498", "3005180920", "3010155648", "3014680795", "3021226419", "3008556682", "1643817", "1220246", "3003128516", "3010220595", "3009973505", "3015876273", "3002806315", "3015440604", "1000125930", "1047843", "3005061536", "3013302242", "3002287318", "3002807830", "3027404764", "3002808269", "1825034", "3003058448", "3038503932", "3002807893", "3016727307", "3002459190", "3030517273", "3003258310", "3006395932", "3000270450", "1020279", "3002807036", "3004142400", "3008599177", "3008812560", "3003477135", "3009971621", "1000115331", "3009888740", "3025603301", "3036756245", "3003755939", "3016851379", "3000717902", "1828288", "3012883081", "1643264", "1000477302", "1824313", "1818910", "3000215205", "3035366890", "3008114965", "3043620689", "3006946276", "3006128100", "3034676720", "3019269298", "3004893332" ], "device_name": "Cerclage, Fixation", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3010", "device_class": "2" } } ] }