{ "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": "190255", "product_res_number": "Z-0316-2022", "event_date_initiated": "2021-11-04", "event_date_created": "2021-12-01", "recall_status": "Terminated", "event_date_terminated": "2023-01-06", "res_event_number": "89007", "product_code": "HSN", "k_numbers": [ "K100886" ], "product_description": "INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS", "code_info": "Model 220223214E, Lot Code 06113718691661809 (GTIN: 00840420125033)", "firm_fei_number": "1043534", "recalling_firm": "Wright Medical Technology Inc", "address_1": "11576 Memphis Arlington Rd", "city": "Arlington", "state": "TN", "postal_code": "38002-9497", "additional_info_contact": "Meghan Wells\n901-867-9971", "reason_for_recall": "The package contents and package labeling do not match.", "root_cause_description": "Nonconforming Material/Component", "action": "Affected consignees were notified via email and/or Federal Express mail. Consignees are asked to immediately quarantine all recalled products on hand and return all affected product to Wright Medical Arlington TN Warehouse as soon as possible. If the consignee has further distributed the affected product, they are asked to notify the applicable parties at once about this recall. The consignee may copy and distribute the notification letter and Wright Medical will work directly with them to collect the recalled items.", "product_quantity": "2 units", "distribution_pattern": "US Nationwide distribution in the states of MI and PA.", "openfda": { "k_number": [ "K110360", "K192994", "K240591", "K191380", "K142117", "K252454", "K202815", "K241482", "K202373", "K210390", "K240259", "K061749", "K122395", "K770421", "K770420", "K240475", "K230462", "K920802", "K191393", "K192778", "K201507", "K152217", "K803167", "K171067", "K230313", "K232002", "K181557", "K053569", "K120906", "K180730", "K222835", "K800530", "K130533", "K230717", "K231699", "K202019", "K051023", "K140749", "K090076", "K761020", "K182878", "K123059", "K162795", "K123954", "K020541", "K761021", "K250641", "K151459", "K242868", "K133585", "K141740", "K211883", "K193067", "K170968", "K223227", "K172633", "K232595", "K183343", "K060544", "K103374", "K131283", "K100886", "K171004", "K153008", "K241999", "K153452", "K253159", "K250037" ], "registration_number": [ "1724955", "1038671", "3027071765", "3014833750", "1220477", "3010141347", "1051526", "1649518", "3014680149", "3013014058", "1450662", "3005144609", "3007922509", "1531174", "2528981", "3008658204", "1225838", "3020745236", "1834179", "3009887475", "2027062", "3033509898", "1720929", "3008421730", "1226544", "1835251", "3006217744", "3023852420", "1721676", "1221934", "3020703621", "3009923578", "1834331", "3004635447", "1423662", "3015526568", "3010375065", "3016084569", "3010009693", "3010047402", "1043653", "1221053", "1057425", "3012234585", "3005596372", "3008868758", "3009973336", "3012275107", "3004153896", "1526534", "3010057495", "2133928", "3004513872", "3011015572", "1822565", "2183744", "2246552", "2090040", "1018470", "3011277306", "3010039400", "1825034", "1424263", "3006791286", "3010667733", "3008650117", "3010470577", "3009882462", "1835572", "2134285", "1020279", "3007740680", "3010123256", "2249615", "3010162973", "3010178296", "3007353762", "3009826895", "3003477135", "3009971621", "3009888740", "3006272282", "3025603301", "3011189525", "3036756245", "3007648354", "1000200989", "1043534", "1424434", "3010462278", "1818910", "3006128100" ], "fei_number": [ "3027071765", "1038671", "3001236277", "3014833750", "1220477", "3003015552", "3010141347", "1051526", "3014680149", "3013014058", "1450662", "1000220733", "3005144609", "3007922509", "3001644153", "2528981", "3008658204", "3020745236", "3002615969", "3009887475", "2027062", "3033509898", "1720929", "3008421730", "3006217744", "3002993297", "3023852420", "1721676", "1221934", "3020703621", "3009923578", "3004635447", "3001452082", "3015526568", "3010375065", "3016084569", "3010009693", "3010047402", "3000215273", "1043653", "1000221916", "3002795782", "1221053", "3012234585", "3005596372", "3001049282", "3008868758", "3009973336", "3012275107", "3004153896", "1526534", "3010057495", "1000306340", "3000205591", "3004513872", "3003128516", "3011015572", "2183744", "2246552", "3002287318", "1018470", "3011277306", "3010039400", "1825034", "3006791286", "3010667733", "3008650117", "3010470577", "3009882462", "1000160371", "1020279", "3007740680", "3010123256", "3007353762", "3009826895", "3003477135", "3009971621", "3002807041", "3009888740", "3006272282", "3025603301", "3011189525", "3036756245", "3007648354", "1000200989", "3000717902", "1043534", "3010462278", "1818910", "3003142829", "3006128100", "3003110073" ], "device_name": "Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3110", "device_class": "2" } } ] }