{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "183239", "product_res_number": "Z-2926-2020", "event_date_initiated": "2020-08-10", "event_date_created": "2020-08-31", "recall_status": "Open, Classified", "res_event_number": "86261", "product_code": "HSN", "k_numbers": [ "K152217" ], "product_description": "The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.", "code_info": "Catalog Number: 350-22-44 Lot numbers: 05144883 and 05144884 Serial Numbers: 6417984, 6417989, 6417996, 6417997, 6417998, 6418002, 6418003, 6488668, 6488673,6488674,6488675.", "firm_fei_number": "1038671", "recalling_firm": "Exactech, Inc.", "address_1": "2320 NW 66th Ct", "city": "Gainesville", "state": "FL", "postal_code": "32653-1630", "additional_info_contact": "Courtney Senter\n352-377-1140", "reason_for_recall": "The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm, were found to have a labeling error. Exactech is recalling the Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm because they were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 3 when the implant size is 4.", "root_cause_description": "Error in labeling", "action": "On August 18, 2020 Exactech sent an Urgent Product Recall Notice to all its consignees with the following instructions:\n-Immediately cease distribution or use of this product.\n-Extend this information to your accounts that may have this product in their possession.\n- Identify and quarantine any of the subject devices in your inventory (including loaner kits).\n-Complete and returned the attached Recall Inventory Response Form to Exactech via email at recalls@exac.com.", "product_quantity": "11 units", "distribution_pattern": "Domestic: CO,FL,OK, PA. \nInternational: Chile", "openfda": { "k_number": [ "K920802", "K133585", "K123954", "K761021", "K181557", "K232002", "K222835", "K162795", "K803167", "K252454", "K250037", "K231699", "K241999", "K061749", "K122395", "K183343", "K770421", "K172633", "K103374", "K202019", "K170968", "K230462", "K800530", "K770420", "K201507", "K211883", "K100886", "K210390", "K110360", "K171004", "K240591", "K761020", "K140749", "K151459", "K240475", "K053569", "K182878", "K242868", "K180730", "K193067", "K020541", "K253159", "K090076", "K240259", "K060544", "K131283", "K192778", "K141740", "K230313", "K120906", "K130533", "K152217", "K192994", "K191380", "K051023", "K230717", "K153452", "K241482", "K202373", "K123059", "K202815", "K232595", "K191393", "K171067", "K223227", "K250641", "K142117", "K153008" ], "registration_number": [ "", "1818910", "3007648354", "3010470577", "3006217744", "3014680149", "2246552", "3009971621", "3023852420", "3005144609", "3016084569", "1043653", "3010047402", "3008421730", "3011015572", "1423662", "1051526", "3006128100", "3013014058", "3036756245", "2183744", "3009973336", "3009923578", "1221934", "3008868758", "1531174", "3009887475", "1526534", "3007740680", "2528981", "1424434", "3025603301", "1721676", "3005596372", "3012275107", "3010667733", "3010162973", "3006791286", "3027071765", "2133928", "3010057495", "1649518", "3004635447", "1043534", "3007922509", "1225838", "2027062", "3033509898", "1724955", "1834331", "3004513872", "3010375065", "1822565", "3009888740", "3008650117", "3010009693", "1038671", "1018470", "3015526568", "3011189525", "3009882462", "3007353762", "1020279", "3010141347", "3008658204", "1221053", "1226544", "2249615", "3010178296", "3010039400", "3009826895", "3006272282", "1835572", "3020703621", "1825034", "3020745236", "1835251", "3014833750", "3012234585", "1834179", "1424263", "1057425", "1000200989", "1720929", "3004153896", "3011277306", "3010123256", "3003477135", "2134285", "1220477", "3010462278", "1450662", "2090040" ], "fei_number": [ "", "1818910", "3002795782", "3001049282", "3007648354", "3003110073", "3010470577", "3001236277", "3006217744", "1000306340", "3014680149", "2246552", "3001644153", "3002807041", "3009971621", "3023852420", "3005144609", "3016084569", "1043653", "1000221916", "3010047402", "3008421730", "3011015572", "1051526", "3000205591", "3006128100", "3013014058", "3036756245", "2183744", "3009973336", "3009923578", "1221934", "3008868758", "3009887475", "1526534", "3007740680", "2528981", "3025603301", "1721676", "3005596372", "3012275107", "3010667733", "3006791286", "3027071765", "3010057495", "3004635447", "1043534", "3007922509", "3000215273", "2027062", "3033509898", "3004513872", "3002287318", "3010375065", "3009888740", "3008650117", "3010009693", "3000717902", "3003015552", "1038671", "1018470", "3015526568", "3011189525", "3009882462", "3007353762", "1020279", "3010141347", "3008658204", "1221053", "3002615969", "1000220733", "3010039400", "3002993297", "3009826895", "3006272282", "3003142829", "3001452082", "3020703621", "1825034", "3020745236", "3014833750", "3012234585", "3003128516", "1000200989", "1720929", "3004153896", "3011277306", "3010123256", "3003477135", "1000160371", "1220477", "3010462278", "1450662" ], "device_name": "Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3110", "device_class": "2" } } ] }