{ "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": "35969", "product_res_number": "Z-0390-05", "event_date_initiated": "2004-10-27", "event_date_posted": "2005-01-12", "recall_status": "Terminated", "event_date_terminated": "2005-12-20", "res_event_number": "30476", "product_code": "KCY", "product_description": "Zimmer™ Orthopaedic Surgical Products, Disposable Cuff, 12'' (30cm), Dual Port, Single Bladder Sterile, Zimmer, Dover, OH USA. The cuff is a sterile, single use product equipped with an integral fill line. The product is packed 10 cuffs per unit.", "code_info": "Cat #60-7070-002-00, Lot #60156865. On 02/11/2005 the firm expanded the recall to include the following codes:  Cat #60-7070-003-00, Lot #60154121, Dual Port Single, Bladder Cuff, Cat #60-7070-006-00, Lot #60166017, Dual Port Single, Bladder Cuff, Cat #60-7070-007-00, Lot #60135936, Dual Port Single, Bladder Cuff, Cat #60-7070-004-00, Lot #60162824, Dual Port Single, Bladder Cuff, Cat #60-7070-005-00, Lot #60161308, Dual Port Single, Bladder Cuff, Cat #60-7070-001-00, Lot #60159350, Dual Port Single, Bladder Cuff, Cat #60-7070-006-00, Lot #60173808, Dual Port Single, Bladder Cuff, Cat #60-7070-005-00, Lot #60171347, Dual Port Single, Bladder Cuff, Cat #60-7070-003-00, Lot #60171346, Dual Port Single, Bladder Cuff, Cat #60-7070-005-00, Lot #60191896, Dual Port Single, Bladder Cuff, Cat #60-7070-003-00, Lot #60180450, Dual Port Single, Bladder Cuff, Cat #60-7070-007-00, Lot #60162831, Dual Port Single, Bladder Cuff, Cat #60-7070-006-00, Lot #60184634, Dual Port Single, Bladder Cuff, Cat #60-7070-004-00, Lot #60173807, Dual Port Single, Bladder Cuff, Cat #60-7070-003-00, Lot #60194151, Dual Port Single, Bladder Cuff, Cat #60-7070-006-00, Lot #60194152, Dual Port Single, Bladder Cuff, Cat #60-7070-004-00, Lot #60188441, Dual Port Single, Bladder Cuff, Cat #60-7070-005-00, Lot #60202399, Dual Port Single, Bladder Cuff, Cat #60-7070-001-00, Lot #60176464, Dual Port Single, Bladder Cuff, Cat 360-7070-003-00, Lot #60205580, Dual Port Single, Bladder Cuff, Cat #60-7070-006-00, Lot #60208192, Dual Port Single, Bladder Cuff, Cat #60-7070-002-00, Lot #60187086. Dual Port Single, Bladder Cuff, Cat #60-7070-005-00, Lot #60178439, Dual Port, Single Bladder Cuff,", "firm_fei_number": "1035617", "recalling_firm": "Zimmer Orthopaedic Surgical Products", "address_1": "2021 Old Mountain Rd", "city": "Statesville", "state": "NC", "postal_code": "28625-1630", "additional_info_contact": "Joyce Elkins\n330-364-9483", "reason_for_recall": "The port/tube bond in the affected cuffs may separate during surgery causing the pressure in the cuff to release.", "root_cause_description": "Other", "action": "Consignees were first notified via certified mail on 10/27/2004. A follow up letter with 2 addtional lots were sent 11/11/2004.", "product_quantity": "Total 45730 cuffs", "distribution_pattern": "Nationwide, Australia, Demark, Germany", "openfda": { "k_number": [ "K860095", "K840206", "K880020", "K952038", "K910449", "K123553", "K925033", "K853802", "K780988", "K953953", "K942303", "K890014", "K162365", "K071140", "K955552", "K050411", "K842963", "K954103", "K012632", "K791759", "K933994", "K860463", "K841558", "K954201", "K945167", "K202919", "K870784", "K871982", "K900104", "K940615", "K112874", "K813231", "K924273", "K910512" ], "registration_number": [ "3010291427", "3030733800", "3005173255", "3015967359", "3023228837", "3012494290", "3016445580", "8010939", "3004905643", "1649518", "3015542154", "3033511104", "1048735", "3013783488", "3009039068", "3014739961", "3010595915", "3009605245", "9613910", "3007997036", "2320762", "2528981", "3003244954", "9681444", "3010759902", "3015495690", "2184171", "3033773618", "1220351", "3002907620", "3006975482", "1720929", "8040278", "3007478714", "3004727093", "2032098", "3011683674", "1650907", "3010190204", "2011171", "3008264111", "2650143", "8010482", "1921846", "3016764932", "3009750712", "3033589330", "3015207155", "9611283", "3011642792", "3014023545", "3012276218", "3015309643", "3016965559", "3010123014", "3011185837", "1058584", "3030516433", "3012536737", "1423537", "3012421607", "1528668", "1722028", "9680215", "3010273872", "3013846070", "1043214", "3006703573", "3025434447", "3015280549", "3011277660", "3006128321", "1421307", "1822565", "3045058049", "3004824601", "3010883047", "1721504", "9611559", "3006535925", "3031887985", "3013730933", "1018470", "3006950086", "3008381116", "3030153385", "3016950436", "2029275", "3014313732", "3032391", "3014830562", "3005698350", "3034520", "3004116008", "2648666", "3005621729", "3031700059", "1526350", "3016678045", "3020163307", "3010410654", "1422634", "3015225571", "1818910", "3009350690", "3014126909", "9680579", "3009056984", "3038700849" ], "fei_number": [ "3010291427", "1000219637", "3001236277", "3030733800", "3005173255", "3015967359", "3023228837", "3012494290", "3016445580", "3004905643", "3015542154", "3033511104", "1048735", "3013783488", "1000220733", "3009039068", "3014739961", "1000306431", "3010595915", "3009605245", "3007997036", "2528981", "3003244954", "3010759902", "3015495690", "1000139815", "3033773618", "3003350313", "1220351", "3002907620", "3006975482", "3003255513", "1720929", "3003748933", "3007478714", "3004727093", "3011683674", "3010190204", "2011171", "3008264111", "1000514656", "1921846", "3016764932", "3009750712", "3033589330", "3015207155", "3011642792", "3004574120", "1000117351", "3003040625", "3014023545", "3012276218", "3015309643", "3016965559", "3011185837", "3010123014", "3030516433", "3012536737", "3012421607", "3001084824", "3002299608", "1000292048", "3001236905", "3010273872", "3013846070", "3002681132", "1043214", "3006703573", "3025434447", "3015280549", "3011277660", "3006128321", "1421307", "3045058049", "3004824601", "3002808440", "1721504", "3006535925", "3031887985", "3013730933", "1018470", "3006950086", "3012599796", "3003058448", "3008381116", "3030153385", "3016950436", "3014313732", "1000136409", "3014830562", "3005698350", "3004116008", "3004216008", "2648666", "3002806816", "3005621729", "2648209", "3031700059", "1526350", "1000203464", "3016678045", "3020163307", "3010410654", "3015225571", "1818910", "3009350690", "3014126909", "3009056984", "3038700849" ], "device_name": "Tourniquet, Pneumatic", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.5910", "device_class": "1" } } ] }