Reported Nov 9, 2016 · Terminated
TANDEM (TM) INTL COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71324038, 71324039, 71324040, 71324041, 71324042,…
Smith & Nephew, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smith & Nephew, Inc. · 1450 E Brooks Rd · Memphis, TN · 38116-1804
Is this the product you have?
- TANDEM (TM) INTL COCR SHELL UHMWPE LINER BIPOLAR
- REF NUMBERS
713240387132403971324040713240417132404271324043713240447132404571324046713240477132404871324049713240507132405171324052713240537132405471324055713240577132405971325039713250407132504171325042713250437132504471325045713250467132504771325048713250497132505071325051713250527132505371325054713250557132505771372047
- Lot codes and dates
39 of 39 products
Products covered by this recall # Product as published 1 REF NUMBER 71324038 Serial Numbers: 13LM19426, 13LM19431, 14BM10263, 14BM10264 2 REF NUMBER 71324039 Serial Numbers: 13LM16207, 14AM08786, 14AM08786A 3 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 4 REF NUMBER 71324041 Serial Numbers: 13LM12870, 13LM12880, 13MM18006, 14AM02713, 14AM12043, 14BM20733, 13LM12874, 13LM17121, 14AM02712, 14AM02714, 14BM00730 5 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 6 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 7 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 8 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 9 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 10 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 11 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 12 REF NUMBER 71324049 Serial Numbers: 13MM10141, 13MM10147, 13MM10150, 13MM10160, 14BM15222, 13MM10143, 13MM10147A, 13MM10157, 13MM13712, 14BM15222A, 13MM10143A, 13MM10149, 13MM10159, 14BM15206 13 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 14 REF NUMBER 71324051 Serial Numbers: 13LM07416, 13LM07418, 14AM02685, 14BM15248, 14BM15249A, 14BM17717, 13LM07417, 14AM02684, 14AM02685A, 14BM15249, 14BM15250 15 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 16 REF NUMBER 71324053 Serial Numbers: 13LM04205, 13LM04207, 13LM04207A, 13LM04213, 14AM21697, 14BM17728 17 REF NUMBER 71324054 Serial Numbers: 13LM04201, 13LM14911, 14AM06637, 14BM10269, 14BM10272, 14BM11528, 13LM04204, 13LM14911A, 14AM06638, 14BM10269A, 14BM11527, 14BM11530 18 REF NUMBER 71324055 Serial Numbers: 13KM22761A, 13KM22761C, 13LM04199A, 13MM13714, 14BM15251, 13KM22761B, 13KM22762, 13MM10153, 14BM03126 19 REF NUMBER 71324057 Serial Numbers: 13LM04196, 14AM12031, 14AM12032, 14BM19299 20 REF NUMBER 71324059 Serial Numbers: 14BM00731, 14BM00731A - Amount recalled
- 5806 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Some Bipolar shells were manufactured with an out of specification retainer groove.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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