Z-0351-2017Class II

Tandem (Tm) Intl Cocr Shell Uhmwpe Liner Bipolar, Ref Numbers: 71324038, 71324039, 71324040, 71324041...

Name: Z-0351-2017 Tandem (Tm) Intl Cocr Shell Uhmwpe Liner Bipolar, Ref Numbers: 71324038, 71324039, 71324040, 71324041...
Creator: Smith & Nephew, Inc.
Published: 2016-08-29
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2016-08-29 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew, Inc. began a recall of TANDEM (TM) INTL COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71324038, 71324039, 71324040, 71324041, 71324042, 71324043, 71324044, 71324045, 71324046... on 2016-08-29. FDA classified it as Class II and gives the reason as "Some Bipolar shells were manufactured with an out of specification retainer groove". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0351-2017
Classification: Class II
Status: Terminated
Initiated: 2016-08-29
Posted: 2016-11-03
Terminated: 2019-08-16
Recalling firm: Smith & Nephew, Inc.
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
Product code: KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Reason for recall: Some Bipolar shells were manufactured with an out of specification retainer groove.
Root cause tag: manufacturing process
FDA root 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0351-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0350-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-09	2016-11-03
Z-0351-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-09	2016-11-03

Product code KWY

K023743Class IISmith & Nephew Global Bipolar SystemSmith & Nephew, Inc. / cleared 2003-01-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)