{ "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": "115508", "product_res_number": "Z-0869-2013", "event_date_initiated": "2012-12-21", "event_date_posted": "2013-02-21", "recall_status": "Terminated", "event_date_terminated": "2013-07-10", "res_event_number": "64185", "product_code": "FWZ", "product_description": "MAYFIELD Composite Series Base Unit Standard, Model (A3101), Rx ONLY, Integra LifeScience Corporation, 4900 Charlemar Drive, Building A, Cincinnati, OH 45227\n\nThe MAYFIELD Base Units are intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where X-ray imaging modalities will be used.", "code_info": "Model # A3101 Base Units Serial No's: SB120016, SB120017, SB120019, SB120020, SB120021, SB120022, SB120023, SB120024, SB120025, SB120026, SB120027, SB120028, SB120029, SB120030, SB120031, SB120032, SB120134, SB120036, SB120037, SB120038, SB120040, SB120042, SB120043, SB120044, SB120045, SB120049, SB120050, SB120051, SB120052, SB120053, SB120054, SB120055, SB120056, SB120057, SB120058, SB120059, SB120060, SB120061, SB120062, SB120063, SB120064, SB120065, SB120066, SB120067, SB120068, SB120069, SB120070, SB120071, SB120072, SB120073, SB120074, SB120075, SB120076, SB120077, SB120078, SB120079, SB120080, SB120081, SB120082, SB120083, SB120084, SB120085, SB120086, SB120087, SB120088, SB120089, SB120090, SB120091, SB120092, SB120093, SB120094, SB120095, SB120096, SB120097, SB120098, SB120099, SB120100, SB120107, SB120108, SB120109, SB120111, SB120112, SB120113, SB120114, SB120115, SB120116, SB120117, SB120118, SB120119, SB120120, SB120121, SB120122, SB120129, SB120131, SB120138 & SB120141.", "firm_fei_number": "3003418325", "recalling_firm": "Integra LifeSciences Corp.", "address_1": "311 Enterprise Dr", "city": "Plainsboro", "state": "NJ", "postal_code": "08536-3344", "additional_info_contact": "Michael Molloy\n513-533-7944", "reason_for_recall": "Integra determined there is a possibility that the Base Units may break during use.", "root_cause_description": "Device Design", "action": "Integra LifeSciences Corporation sent an Urgent Medical Device Recall letter dated December 21, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to stop using the affected product immediately and also remove them from service to prevent any further use of the affected product. Integra would provide an alternative base unit to replace those customers could no longer use. Customers were asked to complete the Recall Acknowledgement and Return Form to ensure they received this information. For assistance customers were instructed to call 1-513-533-7944 or 1-513-533-7946", "product_quantity": "96 units", "distribution_pattern": "Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA & WI. Internationally to Belgium.", "openfda": { "k_number": [ "K810433", "K945415", "K871703", "K871823", "K871840", "K833624", "K840421", "K832472", "K865024", "K821029", "K904826", "K871804", "K882078", "K790674", "K760456", "K931037", "K842700", "K820291", "K864881", "K935381", "K870104", "K864880", "K840422", "K871803", "K860446", "K873370", "K905565", "K871822", "K960019", "K802558", "K871820", "K872900", "K871824", "K871839", "K926225", "K830272", "K870098", "K840684", "K880265", "K813030", "K885215", "K871225", "K890501", "K873139", "K910031", "K944779", "K870101", "K925035", "K871805", "K884928", "K905564", "K897028", "K893969", "K801572", "K821933", "K871819", "K864459", "K830707", "K871821", "K820289", "K830612" ], "registration_number": [ "3010595915", "3005595283", "3009009512", "1060680", "3008489813", "3009655869", "1058584", "3010170586", "3008352384", "3014383485", "1417592", "3023339277", "2028805", "3003418325", "9680168", "9610612", "3006437555", "9680215", "3003604053", "3011824442", "8040233", "3013700547", "3006400329", "1828464", "3006787036", "1825034", "3010202439", "3015531959", "2242450", "3007137643", "9680242", "1223662", "3006538822", "1053198", "3011547624", "3005619998", "1220246", "1218386", "2084346", "1643264", "2011171", "3016851379", "3012595397", "3006535925", "3019269298", "2030380", "3006697241", "1647149", "3005440795", "3017493050", "3045857302", "3004034546", "9710524", "3004111573", "1017294", "3045816907", "3007143236", "3002579136", "1043615", "8043817", "3021226419", "3007663056", "1043572", "3006654680", "9616088", "1223419", "3021839632", "3006154292", "3004608878", "3004414785", "3005061536", "3001415205", "1018470", "3010041511", "3004491689", "1320894", "8010099", "3007307488", "2020550", "3014680784", "3010373530", "3010009693", "3010452421", "2183449", "3015960676", "9710018", "2248030", "2518414", "3027339877", "1526534", "3007740394", "1000655158", "3017410889", "2182536", "3012281713", "3008314176", "3004905643", "3007278668", "3010373263", "3012986524", "3032391", "2031917", "2126670", "1423537", "3010380518", "1043214", "3015425095", "1824206", "1057425", "9614209", "3014004349", "2921578", "2032003", "3005726885", "8021896", "3030926959", "3010331645", "3042872922", "1061124", "3010033804", "3015232217", "3045816902", "3004361903", "1037885", "9616086", "3031582440", "1000655211", "1032347", "1055236", "3011230048", "1526350", "2032098", "3010060157", "1643817", "3009888344", "1421879", "3015974593", "3004361359", "9681599", "8010168", "3012345110", "3001650535", "8043816", "1219602", "3012708860", "3005438755", "3004133257", "3007048220", "3014273557", "2530138", "2916714", "3005285078", "1054241", "3037012186", "3011137372", "3008729549", "1526439", "2320762", "3010123014", "1223962", "3007886583", "3015177648", "3014623126" ], "fei_number": [ "3010595915", "3005595283", "1000115048", "3009009512", "3002902735", "1000219637", "3008489813", "3005747797", "1000159368", "3009655869", "3001236905", "3010170586", "3008352384", "3014383485", "1000208624", "1417592", "3023339277", "3003418325", "1000208866", "1000135620", "3006437555", "1000221916", "3003604053", "1825560", "3011824442", "3003040625", "3013700547", "3006400329", "1828464", "3002806315", "3006787036", "1825034", "3015531959", "2242450", "3007137643", "3006538822", "1053198", "3011547624", "3002929183", "3005619998", "1000453845", "3003029390", "1220246", "1218386", "1643264", "2011171", "3016851379", "3012595397", "3006535925", "3019269298", "1000295034", "3006697241", "3005985723", "3005440795", "3017493050", "3045857302", "1000484507", "3004034546", "1000124817", "3004111573", "1017294", "3045816907", "3007143236", "3003499455", "3002579136", "1000137654", "1043615", "3021226419", "3007663056", "3003340745", "1043572", "3006654680", "3006154292", "3003944071", "3004608878", "3004414785", "3001168737", "3005061536", "3001415205", "1018470", "3010041511", "3004491689", "3003058448", "3006076154", "3007307488", "2020550", "3010373530", "3010009693", "3010452421", "2183449", "3015960676", "2518414", "3027339877", "1526534", "3007740394", "1000655158", "2182536", "3012281713", "3008314176", "3004905643", "3007278668", "3010373263", "3012986524", "3007475226", "3001084824", "1000305774", "2126670", "3010380518", "1043214", "1000125341", "1000112968", "3015425095", "1824206", "2921578", "3014004349", "5870", "3005726885", "1000512168", "3030926959", "3010331645", "3042872922", "3010033804", "3015232217", "3045816902", "3004361903", "1037885", "1000221205", "3031582440", "1000655211", "1032347", "3011230048", "1000112877", "1526350", "3010060157", "1643817", "3009888344", "3015974593", "3004361359", "3002299608", "3003094575", "3012345110", "3001650535", "1219602", "3012708860", "3005438755", "1000306139", "3004133257", "3007048220", "3014273557", "3009504761", "2916714", "3005285078", "3002806725", "1000519805", "3037012186", "1526439", "3008729549", "3010123014", "3007886583", "3015177648", "3001451571", "3005734757", "3014623126" ], "device_name": "Operating Room Accessories Table Tray", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4950", "device_class": "1" } } ] }