{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "113932", "product_res_number": "Z-0296-2013", "event_date_initiated": "2012-09-05", "event_date_posted": "2012-11-15", "recall_status": "Terminated", "event_date_terminated": "2014-04-17", "res_event_number": "63458", "product_code": "KCY", "product_description": "ATS 3000 Automatic Tourniquet System\nw/HOSES AND LOP SENSOR\n\n\nIntended to be used by qualified medical professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities.", "code_info": "Catalog 60-3000-101-00,  Serial # 3005IACJ, 3006JAEP, 3007CADR, 3007EACT, 3007EAKT, 3007GAGR, 3007HABK, 3007KAAR, 3007KAET, 3008CADE, 3008HAHC, 3008LACK, 3009AACN, 3009HABA, 3009LAEF, 3010CABH, 3010DAHG, 3010GAAC, 3010GAAJ, 3011LABL, 3011LABN, 3011LABQ, 3011LACC, 3011LACE, 3011LACF, 3011LACG, 3011LACH, 3011LACJ, 301 1LACK, 3011LACL, 3011LACM, 3011LACN, 3011LACP, 3011LACQ, 3011LACR, 3011LACS, 3011LACT, 3011LACU, 3011LACW, 3011LADA, 3011LADE, 3011LADF, 3011LADG, 3011LADH, 3011LADJ, 3011LADK, 3011LADM, 3011LADP, 3011LADQ, 3011LADR, 3011LADS, 3011LADT, 3011LADU, 3011LADW, 3011LAEA, 3011LAEB, 3011LAEC, 3011LAED, 3011LAEE, 3011LAEF, 3011LAEH, 3012AAAG, 3012AAAK, 3012AAAM, 3012AAAN, 3012AAAP, 3012AAAQ, 3012AAAR, 3012AAAS, 3012AAAT, 3012AAAU, 3012AAAW, 3012AABA, 3012AABB, 3012AABC, 3012AABE, 3012AABG, 3012AABH, 3012AABK, 3012AABL, 3012AABM, 3012AABN, 3012AABQ, 3012AABR, 3012AABS, 3012AABU, 3012AACA, 3012AACB, 3012AACC, 3012AACD, 3012AACE, 3012AACH, 3012AACJ, 3012AACM, 3012AACN, 3012AACP, 3012AACQ, 3012AACR, 3012AACS, 3012AACT, 3012AACW, 3012AADA, 3012AADB, 3012AADC, 3012AADD, 3012AADE, 3012AADF, 3012AADG, 3012BAAA, 3012BAAB, 3012BAAC, 3012BAAD, 3012BAAE, 3012BAAF, 3012BAAG, 3012BAAH, 3012BAAJ, 3012BAAK, 3012BAAL, 3012BAAM, 3012BAAN, 3012BAAP, 3012BAAQ, 3012BAAR, 3012BAAS, 3012BAAT, 3012BAAU, 3012BAAW, 3012BABA, 3012BABB, 3012BABC, 3012BABD, 3012BABE, 3012BABF, 3012BABG, 3012BABH, 3012BABJ, 3012BABK, 3012BABL, 3012BABM, 3012BABN, 3012BABP, 3012BABQ, 3012BABR, 3012BABS, 3012BABT, 3012BABU, 3012BABW, 3012BACE, 3012BACG, 3012BACH, 3012BACJ, 3012BACK, 3012BACL, 3012BACM, 3012BACN, 3012BACP, 3012BACQ, 3012BACR, 3012BACS, 3012BACT, 3012BACU, 3012BACW, 3012BADA, 3012BADB, 3012BADC, 3012BADD, 3012BADG, 3012BADH, 3012BADJ, 3012BADK, 3012BADL, 3012BADN, 3012BADP, 3012BADR, 3012BADS, 3012BADU, 3012BADW, 3012BAEA, 3012BAEB, 3012BAEC, 3012BAEH, 3012BAEJ, 3012BAEL, 3012BAEM, 3012BAEN, 3012BAEQ, 3012BAER  French Catalog 60-3000 301-02 Serial # 3012 AAAE German Catalog 60-300060-301-03, Serial # 3012AAAF Spanish Catalog 60-3000-301-11, Serial # 3012AAAB, 3012AAAC, 3012AACG, 3012BACA, 3012BACB, 3012BACC, 3012BACD Dutch 60-3000-301-12, Serial # 3012AAAA, 3012AAAD, 3012EACA", "firm_fei_number": "1000220733", "recalling_firm": "Zimmer, Inc.", "address_1": "345 E Main St", "city": "Warsaw", "state": "IN", "postal_code": "46580-2746", "additional_info_contact": "Jaime L. Weeks\n574-372-4807", "reason_for_recall": "Zimmer is conducting a voluntary removal of some Zimmer A.T.S. 3000 tourniquets after receiving complaints of both out-of-box failures and failures during surgical procedures on some of the affected units. During failure the unit will alarm, lock into a non-operational mode, and the display screen will go blank. Based on investigation, this problem appears to be due to a counterfeit chip on the", "root_cause_description": "Counterfeit", "action": "Zimmer sent an Urgent Device Removal Notice letter dated September 5, 2012, to all affected customers. Zimmer Distributors and Sales Leadership were notified via E-mail of the pending recallthe product under recall beginnig September 11, 2012. The notification listed the reason for the recall, risks involved, and requested return of the unit for repair To: Zimmer Surgical, Attn: QAlRA Dept. - Recall, 200 West Ohio Avenue, Dover, Ohio 44622 USA The notice asked to ensure all users be made aware of the recall, remove the affected ATS 3000 tourniquest sytem for repair and return the fax back form/acknowledgement certification to 1-888-429-7380 or email it to zimmer3611@stericycle.com. Questions should be directed to 1-8889435167 between 8 a.m. and 5 p.m. EDT.\nFor questions regarding this recall call 574-372-4807.", "product_quantity": "204", "distribution_pattern": "Worldwide Distribution - USA (nationwide) and Internationally to Belgium, Czech Republic, Egypt, France, Germany, Morocco, Netherlands, Romania, Saudi Arabia, Spain, Switzerland, Turkey, and UAE.", "openfda": { "k_number": [ "K112874", "K841558", "K780988", "K071140", "K860463", "K202919", "K791759", "K880020", "K925033", "K860095", "K933994", "K871982", "K924273", "K870784", "K953953", "K853802", "K910449", "K840206", "K942303", "K050411", "K945167", "K123553", "K940615", "K954201", "K012632", "K162365", "K842963", "K813231", "K955552", "K890014", "K910512", "K900104", "K952038", "K954103" ], "registration_number": [ "3031887985", "3004727093", "3004824601", "3006535925", "8010482", "3008264111", "3023228837", "3003244954", "1720929", "3010759902", "1220351", "2320762", "3016950436", "2528981", "3025434447", "3015280549", "3010595915", "3014739961", "3015495690", "3013783488", "1722028", "1822565", "3011642792", "8010939", "3011683674", "3033511104", "3045058049", "3016965559", "3038700849", "3010190204", "3006128321", "1649518", "3033773618", "3033589330", "1422634", "3007997036", "9680215", "2032098", "3030516433", "1818910", "3005173255", "9680579", "3010883047", "8040278", "3009350690", "3004116008", "3006703573", "3009056984", "2648666", "3006975482", "1043214", "1058584", "3016764932", "1650907", "3011185837", "3015225571", "9613910", "3004905643", "3020163307", "3010410654", "3013846070", "1921846", "1048735", "9611283", "3012421607", "3014313732", "3007478714", "2011171", "3012536737", "3009039068", "3005698350", "3009605245", "3010291427", "3008381116", "3015967359", "3031700059", "3014126909", "3032391", "3016445580", "1528668", "3012494290", "3030153385", "3002907620", "3014023545", "3012276218", "3014830562", "1423537", "3034520", "3006950086", "1421307", "2650143", "3030733800", "3010123014", "3010273872", "3015542154", "3011277660", "9681444", "2184171", "3013730933", "1018470", "3016678045", "9611559", "3015309643", "3009750712", "2029275", "3015207155", "1721504", "1526350", "3005621729" ], "fei_number": [ "3031887985", "3004727093", "3004824601", "3006535925", "3008264111", "3023228837", "3001236277", "3003244954", "1720929", "3010759902", "1220351", "3016950436", "2528981", "3025434447", "3015280549", "1721504", "3003040625", "3010595915", "3014739961", "3004574120", "3015495690", "3013783488", "3011642792", "3011683674", "3033511104", "3045058049", "1000306431", "3016965559", "3038700849", "3010190204", "3006128321", "1000220733", "3033773618", "2648209", "3033589330", "3002299608", "3003255513", "3007997036", "1000219637", "3030516433", "1818910", "3005173255", "1000203464", "3003748933", "3009350690", "1000136409", "3001236905", "3004116008", "3006703573", "3009056984", "2648666", "3006975482", "1043214", "3016764932", "3001084824", "3011185837", "3015225571", "3003350313", "3004905643", "1000292048", "3020163307", "1000514656", "3010410654", "3013846070", "1921846", "1048735", "3012421607", "3014313732", "3007478714", "1000117351", "2011171", "3012536737", "3009039068", "3005698350", "3009605245", "3010291427", "3008381116", "3002806816", "3015967359", "3031700059", "3014126909", "3016445580", "3012494290", "3002681132", "3030153385", "3002907620", "3014023545", "3012276218", "3014830562", "3006950086", "1421307", "3030733800", "1000139815", "3010123014", "3010273872", "3015542154", "3011277660", "3013730933", "1018470", "3016678045", "3012599796", "3015309643", "3009750712", "3015207155", "3002808440", "3003058448", "3004216008", "1526350", "3005621729" ], "device_name": "Tourniquet, Pneumatic", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.5910", "device_class": "1" } } ] }