Class 2 Device Recall TANDEM Bipolar Hip System

• Date Initiated by Firm: August 29, 2016
• Create Date: November 03, 2016
• Recall Status: Terminated on August 16, 2019
• Recall Number: Z-0351-2017
• Recall Event ID: 75283
• 510(K)Number: K023743
• Product Classification: Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented - Product Code KWY
• Product: TANDEM (TM) INTL COCR SHELL UHMWPE LINER BIPOLAR, ; REF NUMBERS: ; 71324038, 71324039, 71324040, 71324041, 71324042, 71324043, 71324044, 71324045, 71324046, 71324047, 71324048, 71324049, 71324050, 71324051, 71324052, 71324053, 71324054, 71324055, 71324057, 71324059, 71325039, 71325040, 71325041,71325042, 71325043, 71325044, 71325045, 71325046, 71325047, 71325048, 71325049, 71325050, 71325051, 71325052, 71325053, 71325054, 71325055, 71325057, 71372047
• Code Information: REF NUMBER 71324038 Serial Numbers: 13LM19426, 13LM19431, 14BM10263, 14BM10264 REF NUMBER 71324039 Serial Numbers: 13LM16207, 14AM08786, 14AM08786A REF NUMBER 71324040 Serial Numbers: 13LM12963, 13LM17120, 13MM18005, 14BM00728, 14BM10265A, 14BM16804, 13LM12964, 13MM18000, 14AM02711, 14BM00729, 14BM10266, 14BM16815, 13LM16210, 13MM18001, 14AM12034, 14BM01149, 14BM10266A, 13LM17118, 13MM18003, 14BM00727, 14BM10265, 14BM10268 REF NUMBER 71324041 Serial Numbers: 13LM12870, 13LM12880, 13MM18006, 14AM02713, 14AM12043, 14BM20733, 13LM12874, 13LM17121, 14AM02712, 14AM02714, 14BM00730 REF NUMBER 71324042 Serial Numbers: 13LM14881, 13MM02907, 13MM09996, 14BM00737, 14BM06960, 14BM16819A, 13LM14881A, 13MM02907A, 13MM09998, 14BM01141, 14BM06961, 14BM16820, 13LM14883, 13MM02908, 13MM09998A, 14BM01144, 14BM14307, 14BM16822, 13LM14883A, 13MM02909, 14AM12035, 14BM03060, 14BM14318, 14BM16825, 13LM14885, 13MM02910, 14AM12042, 14BM03110, 14BM16819 REF NUMBER 71324043 Serial Numbers: 13LM17122, 13LM19387, 13MM04114, 13MM04124, 13MM08123, 14AM12038, 13LM17123, 13LM19387A, 13MM04116, 13MM04126, 13MM08124, 14AM12038A, 13LM17123A, 13LM19389, 13MM04117, 13MM04126A, 13MM08124A, 14BM00775, 13LM17124, 13MM04108, 13MM04118, 13MM08116, 13MM08126, 14BM00775A, 13LM17125, 13MM04108A, 13MM04120, 13MM08116A, 13MM09999, 14BM01146, 13LM17126, 13MM04111, 13MM04123, 13MM08118, 13MM10001, 13LM19386, 13MM04112, 13MM04123A, 13MM08121, 14AM07555 REF NUMBER 71324044 Serial Numbers: 13KM22764, 13LM00822, 13LM00828, 13LM00831, 13LM00899, 13LM00900, 13LM06362, 13LM06363, 13LM06364, 13LM17127, 13LM17128, 13LM17128A, 13LM17129, 13LM17132, 13LM17133, 13LM17134, 13LM17136, 13LM17157, 13LM17160, 13MM04130, 13MM04130A, 13MM04132, 13MM04132A, 13MM04134, 13MM04135, 13MM04136, 13MM04139, 13MM04139A, 13MM04141, 13MM10009, 14AM15528, 14AM15529, 14AM21699, 14AM21701, 14AM21704, 14AM21707, 14AM24082, 14AM24083, 14AM24084, 14AM24084A, 14AM24085, 14AM24086, 14AM24087, 14AM24088, 14AM24091, 14AM24098, 14BM04004, 14BM04014, 14BM04015, 14BM04017, 14BM04019, 14BM04021, 14BM06965, 14BM06966, 14BM06967, 14BM06970, 14BM06971, 14BM06973, 14BM06975, 14BM06975A, 14BM06977, 14BM06977A, 14BM08966, 14BM08970, 14BM08971, 14BM12189, 14BM12192, 14BM12194, 14BM12195, 14BM14321, 14BM14805, 14DM11275 REF NUMBER 71324045 Serial Numbers: 13KM24095, 13KM24095A, 13KM24097, 13KM24099, 13LM04114, 13LM06366, 13LM17165, 13LM17169, 13LM17169A, 13MM04143, 14AM00467, 14AM00469, 14AM00474, 14AM00478, 14AM00485, 14AM00485A, 14AM00490, 14AM00490A, 14AM02715, 14AM02716, 14AM02717, 14AM02717A, 14AM02718, 14AM02718A, 14AM12041, 14AM16532, 14AM24089, 14AM24090, 14BM03989, 14BM13827, 14BM17706, 14BM17710, 14BM17712, 14BM17712A, 14BM17713 REF NUMBER 71324046 Serial Numbers: 13KM24091, 13LM15742, 13MM13862, 14AM02708A, 14AM24102A, 14BM04026, 13KM24092, 13LM15743, 13MM13863, 14AM02709, 14AM24103, 14BM14323, 13KM24093, 13LM15743A, 13MM13864, 14AM16514, 14AM24103A, 14BM14324, 13LM04070, 13LM15745, 13MM13865, 14AM16514A, 14AM24108, 14BM14324A, 13LM04072, 13LM15745A, 13MM13866, 14AM16515, 14AM24109, 14BM14327, 13LM04073, 13LM15746, 13MM13867, 14AM16520, 14BM00835, 14BM19649, 13LM11741, 13LM15747, 14AM02704, 14AM16521, 14BM01154, 14BM20553, 13LM11741A, 13MM13857, 14AM02705, 14AM16522, 14BM01157, 13LM15736, 13MM13858, 14AM02706, 14AM16524, 14BM04024, 13LM15741, 13MM13859, 14AM02707, 14AM24101, 14BM04024A, 13LM15741A, 13MM13860, 14AM02708, 14AM24102, 14BM04025 REF NUMBER 71324047 Serial Numbers: 13LM00813, 13LM14897, 13MM14128, 14AM00453, 14AM16528, 14BM14334, 13LM01891, 13LM14899, 13MM14134, 14AM16526, 14BM14332, 13LM01892, 13MM13677, 13MM18008, 14AM16526A, 14BM14333, 13LM14895, 13MM14126, 13MM18008A, 14AM16526B, 14BM14333A REF NUMBER 71324048 Serial Numbers: 13LM01893, 13LM14908, 13MM13695A, 14AM00586B, 14AM16531, 14BM08987, 13LM01894, 13LM14909, 14AM00527, 14AM12010, 14BM03036, 14BM08988, 13LM01895, 13LM14910, 14AM00532, 14AM12012, 14BM03036A, 14BM08988A, 13LM14903, 13LM14910A, 14AM00541, 14AM12014, 14BM08979, 14BM14335, 13LM14905, 13MM13470, 14AM00562, 14AM12014A, 14BM08979A, 14BM14336, 13LM14905A, 13MM13691, 14AM00563, 14AM12015, 14BM08979B, 14BM14337, 13LM14906, 13MM13692, 14AM00567, 14AM16529, 14BM08980, 14BM14338, 13LM14906A, 13MM13695, 14AM00586, 14AM16530, 14BM08983, 14BM14339 REF NUMBER 71324049 Serial Numbers: 13MM10141, 13MM10147, 13MM10150, 13MM10160, 14BM15222, 13MM10143, 13MM10147A, 13MM10157, 13MM13712, 14BM15222A, 13MM10143A, 13MM10149, 13MM10159, 14BM15206 REF NUMBER 71324050 Serial Numbers: 13KM20614A, 13LM07412A, 14AM00595, 14AM12027A, 14BM03022A, 14BM15227, 13KM20615, 13LM07413A, 14AM00599, 14AM12029, 14BM03022B, 14BM15243, 13LM06367, 13LM07414, 14AM00603, 14AM12030, 14BM03023, 14BM15246, 13LM06370, 13LM07414B, 14AM06642, 14BM03018, 14BM03023A, 14BM15247, 13LM06371, 13LM07415, 14AM06643, 14BM03021, 14BM03025, 13LM06371A, 13LM07415A, 14AM06644, 14BM03021A, 14BM03025A, 13LM07412, 14AM00593, 14AM12027, 14BM03022, 14BM03026 REF NUMBER 71324051 Serial Numbers: 13LM07416, 13LM07418, 14AM02685, 14BM15248, 14BM15249A, 14BM17717, 13LM07417, 14AM02684, 14AM02685A, 14BM15249, 14BM15250, REF NUMBER 71324052 Serial Numbers: 13LM07419, 13LM07425, 13MM13701A, 14BM03065, 14BM11515, 14BM19330, 13LM07419B, 13MM10273, 14AM02686, 14BM03066, 14BM11526, 14CM21388, 13LM07420B, 13MM13698, 14AM02687, 14BM03067, 14BM19328, 13LM07420D, 13MM13700, 14AM02688, 14BM03119, 14BM19328A, 13LM07422, 13MM13700A, 14AM02689, 14BM11513, 14BM19328B, 13LM07424, 13MM13701, 14AM21904, 14BM11514, 14BM19329 REF NUMBER 71324053 Serial Numbers: 13LM04205, 13LM04207, 13LM04207A, 13LM04213, 14AM21697, 14BM17728 REF NUMBER 71324054 Serial Numbers: 13LM04201, 13LM14911, 14AM06637, 14BM10269, 14BM10272, 14BM11528, 13LM04204, 13LM14911A, 14AM06638, 14BM10269A, 14BM11527, 14BM11530 REF NUMBER 71324055 Serial Numbers: 13KM22761A, 13KM22761C, 13LM04199A, 13MM13714, 14BM15251, 13KM22761B, 13KM22762, 13MM10153, 14BM03126 REF NUMBER 71324057 Serial Numbers: 13LM04196, 14AM12031, 14AM12032, 14BM19299 REF NUMBER 71324059 Serial Numbers: 14BM00731, 14BM00731A REF NUMBER 71325039 Serial Numbers: 13LM14010, 13MM15827A, 14AM14596, 14AM18791, 13MM15827, 14AM03055, 14AM14596A, 14BM18438 REF NUMBER 71325040 Serial Numbers: 13LM11504, 13MM09291, 14AM05485, 14BM00723, 14BM05787, 13LM12921, 14AM03739, 14AM16892, 14BM00725, 14BM05787A REF NUMBER 71325041 Serial Numbers: 13LM12928, 13LM14007A, 13MM01327, 14AM09899, 14AM16953, 13LM12930, 13MM01324, 14AM05489, 14AM15512, 14BM05789, 13LM14007, 13MM01324A, 14AM05492, 14AM15514 REF NUMBER 71325042 Serial Numbers: 13LM05334, 13LM05339, 13LM12934, 14AM05499, 14AM15509, 14BM05790, 13LM05335, 13LM05341, 13LM13889, 14AM05500, 14AM15510, 14BM05791, 13LM05337, 13LM12933, 13LM13891, 14AM09891, 14AM16954, 14BM05792, 13LM05338, 13LM12933A, 14AM05498, 14AM09895, 14AM23046, 14BM17724 REF NUMBER 71325043 Serial Numbers: 13LM10125, 13LM10151, 14AM05505A, 14AM15505A, 14AM23041, 14BM17626, 13LM10126, 13LM14912, 14AM09900, 14AM15506, 14AM23044, 13LM10127, 14AM03759, 14AM09902, 14AM15507, 14BM05794, 13LM10128, 14AM05501, 14AM15503, 14AM16955, 14BM10399, 13LM10129, 14AM05502, 14AM15503A, 14AM16955A, 14BM11540, 13LM10130, 14AM05505, 14AM15504, 14AM16957, 14BM11540A REF NUMBER 71325044 Serial Numbers: 13KM09768, 13MM08132, 13MM08136A, 14AM13561A, 14AM16967, 14AM23022, 13LM03438, 13MM08133, 13MM08137, 14AM13561B, 14AM16968, 14BM05795, 13LM03439, 13MM08134, 14AM13557, 14AM16960, 14AM16969, 14BM10259, 13LM03443, 13MM08135, 14AM13560, 14AM16961, 14AM16971, 14BM10260, 13LM03444, 13MM08135A, 14AM13560A, 14AM16963, 14AM16971A, 13MM08130, 13MM08136, 14AM13561, 14AM16965, 14AM23010 REF NUMBER 71325045 Serial Numbers: 13LM05344, 13LM19404A, 13MM08035, 14AM13564, 14AM16972, 14BM03983, 13LM19400, 13LM19407, 14AM09995, 14AM16536, 14AM16973, 14BM03988, 13LM19402, 13MM08033, 14AM09996, 14AM16537, 14AM16973A, 14BM03988A, 13LM19403, 13MM08034, 14AM13563, 14AM16537A, 14AM16974, 14BM05796, 13LM19404, 13MM08034A, 14AM13563A, 14AM16539, 14BM03981 REF NUMBER 71325046 Serial Numbers: 13LM05346, 13LM19451, 13MM09247, 14AM16534, 14AM23073, 14BM11534, 13LM14918, 13MM01341, 14AM09997, 14AM16975, 14AM23073A, 14BM11536, 13LM14922, 13MM09245, 14AM09998, 14AM16976, 14AM23076, 13LM19449, 13MM09245A, 14AM09999, 14AM16976A, 14AM23076A REF NUMBER 71325047 Serial Numbers: 13LM13911, 14AM03760, 14AM12055, 14AM13566A, 14AM23079, 13LM13912, 14AM12045, 14AM12062, 14AM15499, 14BM11537, 13LM13912A, 14AM12050, 14AM13566, 14AM15501 REF NUMBER 71325048 Serial Numbers: 13LM13988, 13MM09279, 14AM05514A, 14AM16982, 14BM11532, 13LM13988A, 13MM09279A, 14AM16979, 14AM23081, 14BM11533, 13LM14006, 14AM05512, 14AM16979A, 14AM23084, 14BM11533A, 13LM19458, 14AM05514, 14AM16980, 14AM23084A, 14CM06925 REF NUMBER 71325049 Serial Numbers: 13LM05330, 13LM05332A, 13MM09289, 14AM08792, 14AM16986, 13LM05330A, 13LM13904, 13MM09290, 14AM16984, 14AM23086, 13LM05332, 13LM13904A, 14AM08791, 14AM16985, 14AM23089 REF NUMBER 71325050 Serial Numbers: 13LM03426, 13LM03431, 13LM13897A, 14AM16990, 14BM10261, 13LM03426A, 13LM05329, 13LM13897B, 14AM16990A, 14BM10262, 13LM03430, 13LM08816, 14AM03765, 14AM16991, 14BM10262A, 13LM03430A, 13LM13897, 14AM12052, 14AM17003 REF NUMBER 71325051 Serial Numbers: 13LM10120, 13LM10122, 14AM03766, 14AM15473, 14AM16993A, 14AM23129, 13LM10121, 13LM17626, 14AM05511, 14AM16993, 14AM23128, 14BM03984 REF NUMBER 71325052 Serial Numbers: 13LM03432, 13LM10117, 14AM16995, 14AM23119, 14BM10278, 13LM03434A, 14AM05537, 14AM17000, 14AM23124 REF NUMBER 71325053 Serial Numbers: 13LM12937, 14AM05474A, 14AM15517, 14BM11539A, 14BM11539D, 13MM00436, 14AM05476, 14AM15517A, 14BM11539B, 14AM05474, 14AM15516, 14BM11539, 14BM11539C REF NUMBER 71325054 Serial Numbers: 13LM03435, 14AM03757, 14AM16997, 14BM15265 REF NUMBER 71325055 Serial Numbers: 13LM12939, 13MM01365A, 14AM15441, 14BM10280, 13MM01365, 14AM15440, 14AM23118 REF NUMBER 71325057 Serial Numbers: 14BM00722, 14BM00722A REF NUMBER 71372047 Serial Numbers: 13LM05789
• Recalling Firm/ Manufacturer: Smith & Nephew, Inc.; 1450 E Brooks Rd; Memphis TN 38116-1804
• For Additional Information Contact: Joe Metzger; 978-749-1330
• Manufacturer Reason for Recall: Some Bipolar shells were manufactured with an out of specification retainer groove.
• FDA Determined Cause: 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.
• Quantity in Commerce: 5806 units
• Distribution: 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KWY and Original Applicant = SMITH & NEPHEW, INC.