{ "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": "149948", "product_res_number": "Z-0350-2017", "event_date_initiated": "2016-08-29", "event_date_created": "2016-11-03", "recall_status": "Terminated", "event_date_terminated": "2019-08-16", "res_event_number": "75283", "product_code": "KWY", "k_numbers": [ "K023743" ], "product_description": "TANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR, \nREF NUMBERS: \n71322040, 71322041, 71322042, 71322043, 71322044, 71322045, 71322046, 71322047, 71322048, 71322049, 71322050, 71322051, 71322052, 71322053, 71322054, 71322055, 71322057", "code_info": "REF NUMBER 71322040 Serial Numbers: 14AM13511, 14AM13511A  REF NUMBER 71322041 Serial Numbers: 14AM21654  REF NUMBER 71322042 Serial Numbers: 13LM06353, 13MM17938, 13MM17940, 14AM01852, 14AM04660, 14AM04662, 13LM06354, 13MM17939 \t\t\t\t REF NUMBER 71322043 Serial Numbers: 13KM21801, 13LM09191, 13MM09504, 14AM01946, 14AM04663, 14BM15318, 13LM06356, 13LM09204, 13MM09507, 14AM02029, 14AM21664, 14BM15318A, 13LM06356A, 13MM02843, 14AM01855, 14AM02046, 14BM01137, 14BM19345  REF NUMBER 71322044 Serial Numbers:  13KM21825, 13LM09225, 13MM09510, 14AM02112, 14AM04670, 14BM08940A, 13KM24083, 13LM09236, 13MM09517, 14AM02118, 14AM13546, 13KM24083A, 13LM09236A, 13MM09517A, 14AM02120, 14BM01133, 13KM24084, 13MM02853, 13MM09517B, 14AM02120A, 14BM01133A, 13LM06357, 13MM02857, 13MM14125, 14AM04667, 14BM08938, 13LM06361, 13MM02857A, 13MM14135, 14AM04668, 14BM08940   REF NUMBER 71322045 Serial Numbers:  13KM17382, 13KM24087, 13MM02862A, 13MM17942, 14AM04672, 14BM08950, 13KM21826, 13LM00819, 13MM09520, 13MM17943, 14AM13549, 14BM08958,  13KM22753, 13LM09243, 13MM09520A, 13MM17943A, 14AM21666, 14BM15339, 13KM22755, 13LM09247, 13MM09523, 14AM02117, 14AM21669, 13KM24086,  13MM02862, 13MM17941, 14AM02117A, \t14BM06955  \t REF NUMBER 71322046 Serial Numbers:  13KM17387, 13LM09274, 13LM11684, 13MM09524A, 14AM04682, 14BM15355, 13KM22756, 13LM09275, 13MM02888A, 13MM09526, 14AM13552, 14BM15358, 13KM22756A, 13LM09275A, 13MM02892, 13MM09527, 14AM21677, 14BM16787,  13KM24089, 13LM09278, 13MM02893, 13MM09991, 14AM21681, 14BM19253, 13LM00818, 13LM09281, 13MM02893A, 14AM02121, 14BM06952, 13LM00818A, 13LM11683, 13MM02897, 14AM02121A, 14BM12173, 13LM09258, 13LM11683A, 13MM09524, 14AM02124, 14BM12174   REF NUMBER 71322047 Serial Numbers:  13LM00809, 13LM00817B, 13LM11695, 13MM02901, 14AM21693, 14BM16794A, 13LM00809A, 13LM09285A, 13LM11700, 13MM02901B, 14BM12175, 14BM16795, 13LM00810, 13LM09289, 13LM14993, 13MM09528, 14BM12176, 14BM16795A, 13LM00816, 13LM09289A, 13LM15004, 13MM09529, 14BM16791, 13LM00817A,  13LM11689, 13MM02900, 14AM02127, 14BM16794   REF NUMBER 71322048 Serial Numbers:  13LM01881, 13LM01886, 13LM11730, 13MM02905, 14AM13555, 14BM08977, 13LM01882, 13LM11707, 13LM11730A, 13MM09994, 14AM16949, 14BM12177, 13LM01883, 13LM11707A, 13LM11731, 13MM17944, 14AM16951, 13LM01883A, 13LM11709, 13LM14017, 13MM17947, 14BM08976   REF NUMBER 71322049 Serial Numbers:  13LM01887, 13LM01889, 13LM11734, 13MM02906, 13MM13869A, 13MM14122A, 13LM01888, 13LM01890, 13LM14022, 13MM13868, 13MM14119, 14BM12178, 13LM01888A, 13LM11732, 13LM14023, 13MM13869, 13MM14122, 14BM12178A    REF NUMBER 71322050 Serial Numbers:  13LM11735, 13LM12855, 13LM15017, 13MM13870, 13MM17994, 13LM12820, 13LM12957, 13LM15751, 13MM13871, 13MM17995, 13LM12852, 13LM12960, 13LM15751A, 13MM13871A, 14BM01122  REF NUMBER 71322051 Serial Numbers:  13LM12961, 13LM12962A, 13LM14032A, 13LM14035, 13MM13872, 14BM16796, 13LM12961A, 13LM14025, 13LM14033, 13LM14037, 13MM13873, 14BM16796A, 13LM12962, 13LM14032, 13LM14034A, 13LM16186, 13MM17997   REF NUMBER 71322052 Serial Numbers:  13LM16191, 14AM02691, 14AM02694, 14AM04689, 14BM12179A, 14BM12182A, 13LM16192, 14AM02691A, 14AM04683, 14AM21695, 14BM12179B, 14BM12182B,  13LM16193, 14AM02692, 14AM04687, 14AM21695A, 14BM12181, 13LM16193A, 14AM02693, 14AM04688, 14BM12179, 14BM12182   REF NUMBER 71322053 Serial Numbers:  13LM16195, 14AM02695, 14AM02697, 14AM16934, 14AM21696, 14BM12183, 13LM16197,  14AM02696, 14AM06639, 14AM16935, 14AM21696A, 14BM12184   REF NUMBER 71322054 Serial Numbers:  13KM22757, 13LM16204, 14AM02699, 14AM02701B, 14AM16936, 14BM12186, 13KM22758, 13LM16204A, 14AM02700, 14AM02702, 14AM16937, 13LM16203, 13MM03205, 14AM02701, 14AM02702A, 14AM16937A, 13LM16203A, 14AM02698,  14AM02701A, 14AM02703, 14BM12185   REF NUMBER 71322055 Serial Numbers:  13LM16205, 14AM02710A, 14AM16940, 14BM01110A, 14BM12187, 14AM02710, 14AM16938, 14BM01110, 14BM01110B   REF NUMBER 71322057 Serial Numbers:  14AM16597, 14AM16597A", "firm_fei_number": "1020279", "recalling_firm": "Smith & Nephew, Inc.", "address_1": "1450 E Brooks Rd", "city": "Memphis", "state": "TN", "postal_code": "38116-1804", "additional_info_contact": "Joe Metzger\n978-749-1330", "reason_for_recall": "Some Bipolar shells were manufactured with an out of specification retainer groove.", "root_cause_description": "Process control", "action": "The firm initiated their recall by FedEx and Email on 08/29/2016 to hospitals and distributors and requested the return of any in stock product. International consignees were notified by Email on 08/29/2016. Additionally, the firm notified the US physician of the issue by overnight letter on 09/08/2016.", "product_quantity": "2352 units", "distribution_pattern": "Nationwide and Australia, Belgium, Canada, China, Cyprus, France, Germany, India, Italy, Japan, Korea, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Singapore, South Africa, Spain, Switzerland, Thailand, Turkey, United Arab Emirates", "openfda": { "k_number": [ "K152439", "K982812", "K101670", "K905370", "K925420", "K853795", "K132539", "K944132", "K982389", "K953977", "K925536", "K123991", "K823482", "K052990", "K941534", "K842344", "K253357", "K961793", "K100151", "K991990", "K180130", "K873514", "K945518", "K900051", "K833991", "K040947", "K223441", "K980801", "K953510", "K191016", "K023743", "K945793", "K080979", "K926387", "K112019", "K884658", "K970447", "K781735", "K220492", "K062693", "K982447", "K925153", "K010081", "K810062", "K855231", "K872019", "K163081", "K881289", "K823726", "K082468", "K200709", "K791823", 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"3010898856", "3014252644", "3007740680", "3008110533", "3036756245", "3003477135", "3003015552", "3025603301", "3000196378", "3002807113", "3013176080", "3016438761", "3034676720", "3035366890", "3002807038", "3003070421", "3002806603", "3009106092", "3002806725", "3014763043", "3001278222", "3002459190", "3006017180", "2528981", "3003916006", "3002807310", "3015207155", "3015516266", "3013791180", "3013450937" ], "device_name": "Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3390", "device_class": "2" } } ] }