{ "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": "124879", "product_res_number": "Z-0779-2014", "event_date_initiated": "2013-05-06", "event_date_posted": "2014-01-16", "recall_status": "Terminated", "event_date_terminated": "2016-04-18", "res_event_number": "67179", "product_code": "ERL", "k_numbers": [ "K011444", "K965080" ], "product_description": "Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only\r\n\r\nMIA16 attachments are intended for use with Motor Systems for cutting and shaping bones, including the spine and cranium.", "code_info": "ALL LOTS", "firm_fei_number": "1045834", "recalling_firm": "The Anspach Effort, Inc.", "address_1": "4500 Riverside Drive", "city": "Palm Beach Gardens", "state": "FL", "postal_code": "33410-4235", "additional_info_contact": "561-627-1080", "reason_for_recall": "Product did not reach expected sterility assurance level", "root_cause_description": "Unknown/Undetermined by firm", "action": "The firm, Aspach, sent an \"URGENT: MEDICAL DEVICE LABELING CORRECTION\" letter dated May 13, 2013 to its consignees/customers. The letter described the product, problem and actions to be taken. The consignees/ customers were instructed that Sterrad 100S system should not be used on the MIA 16 attachment (the information only applies to only Sterrad sterilization of this devices and not to any other attachments.), and complete and return the Return Receipt Requested Customer Reply form via fax to: 1-800-327-6661 or email: ProductSupportTeam@synthes.com. If you distribute any of the products to other services or facilities, please forward this information as appropriate.\r\n\r\nShould you have any queries, please do not hesitated to contact Anspach Product Support at (800) 327-6887. Hours of Operation are 8:30am-5:30pm Eastern Standard Time or email: ProductSupportTeam@synthes.com.", "product_quantity": "183", "distribution_pattern": "Nationwide Distribution: FL, IL, CA. IN, MI, CA, NJ, TX, NE, NC, OR, PA, TN, DC, UT, CO, MO, KY, MD, WV, NY, and MN.", "openfda": { "k_number": [ "K973286", "K080052", "K012456", "K983050", "K822008", "K943569", "K212650", "K940710", "K003994", "K965080", "K841813", "K854331", "K972865", "K862807", "K990038", "K974174", "K792159", "K083720", "K781418", "K034004", "K011381", "K171840", "K945438", "K131053", "K073633", "K905800", "K791407", "K161376", "K950964", "K002828", "K914346", "K081277", "K963246", "K021098", "K981041", "K020594", "K073255", "K221184", "K121678", "K943108", "K962163", "K011321", "K972584", "K833875", "K964548", "K243280", "K053262", "K954989", "K972453", "K831946", "K954715", "K040300", "K081814", "K802463", "K954796", "K163247", "K080722", "K981637", "K041523", "K992994", "K854332", "K152744", "K200318", "K972057", "K190715", "K150969", "K873154", "K940016", "K951263", "K002224", "K944476", "K133133", "K213221", "K112593", "K833874", "K021811", "K143492", "K180063", "K023070", "K041413", "K211490", "K970965", "K141935", "K945659", "K150728", "K952681", "K983224", "K152641", "K961192", "K233958", "K161101" ], "registration_number": [ "9610617", "3005382983", "3015453963", "3007456622", "9681479", "3010707607", "3001592626", "9611253", "1058584", "3002807315", "2029275", "3002809144", "3011543740", "3003418325", "8010516", "3014479313", "3011024991", "8030965", "1828288", "3003678543", "1037007", "3011697028", "3011050570", "3009417901", "3015440604", "3011300255", "1045254", "3010659131", "3010202439", "2648623", "2650143", "3007305485", "3002807314", "8043792", "3015882686", "3010155648", "2649614", "1422375", "1526711", "3010264076", "2936485", "3007279848", "9612501", "3025764223", "3018094310", "3016172274", "3006891611", "1045834", "3004111573", "1017294", "3003800209", "1048735", "9611102", "1926681", "3014342096", "3003790304", "8044015", "3010972758", "1649518", "3010141593", "3008868758", "1833986", "3012336822", "3003595343", "1220477", "1018470", "3005333358", "3008812560", "3040335671", "2020550", "3027339887", "3005820796", "3030733800", "3002808022", "2133786", "3004598644", "1526534", "1226544", "3005210579", "3012494290", "3017210488", "9616696", "3010363503", "3005282635", "3021632375", "2085199", "3000126629", "1834331", "3007997036", "3017521423", "3008253300", "3004464325", "3001239363", "3009420598", "2133641", "9614434", "3015173212", "1061124", "3013557562", "3004774118", "8010177", "3008837339", "3033509898", "3009039068", "3008087383", "2647346", "3012607373", "1526611", "3015399803", "3010163695", "1057421", "9680741", "2648666", "3005172759", "3003933619", "3036756245", "3010375018", "1928237", "2183744", "3025603301", "1319639", "3010173425", "1625507", "3034676720", "3010273872", "3015967359", "3033536319", "3002806603", "3015212339", "2953359", "3002807310", "8010155", "1222928", "3014279513" ], "fei_number": [ "3003128516", "3005382983", "3015453963", "3004169071", "1000138054", "3007456622", "1000219637", "3010707607", "3001592626", "3002807315", "3002809144", "3011543740", "3003418325", "3014479313", "3011024991", "1828288", "3003678543", "2648209", "1037007", "3011697028", "3011050570", "3009417901", "3015440604", "3011300255", "1045254", "3010659131", "3002807687", "1000120613", "2648623", "3007305485", "3002807314", "3015882686", "3003755849", "3002807036", "3010155648", "2649614", "1000306340", "3002821504", "1526711", "3010264076", "2936485", "3007279848", "4476", "3001236277", "3025764223", "3018094310", "3016172274", "3006891611", "1000306431", "1045834", "3004111573", "1017294", "3003800209", "3002807305", "1048735", "1000160732", "3000203466", "1926681", "3014342096", "3003790304", "3010972758", "3004536551", "3000215205", "3010141593", "3008868758", "3002808273", "3012336822", "3003595343", "1220477", "3005601686", "1018470", "3005333358", "3008812560", "3040335671", "2020550", "3027339887", "3005820796", "3030733800", "3002808269", "3002808022", "3003495548", "3004598644", "1526534", "3005210579", "3002808268", "3012494290", "3017210488", "3010363503", "3005282635", "3021632375", "3000126629", "3007475226", "3007997036", "3017521423", "3008253300", "3004464325", "1000139790", "3001239363", "3009420598", "1000512168", "3003164255", "3015173212", "3013557562", "3008837339", "3033509898", "3009039068", "3008087383", "2647346", "3012607373", "1526611", "3008599177", "1000139987", "3000204692", "3015399803", "3010163695", "2648666", "3005172759", "3003933619", "3036756245", "3010375018", "1928237", "2183744", "3025603301", "1625507", "3034676720", "3010273872", "3015967359", "3033536319", "3002806603", "3015212339", "1000022662", "3002807310", "3002808001", "3014279513" ], "device_name": "Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece", "medical_specialty_description": "Ear, Nose, Throat", "regulation_number": "874.4250", "device_class": "2" } } ] }