CLASS II Device recall · Reported 16 Jul 2014 · FDA Enforcement Report
M/L Taper Hip Stem Standard & Extended Offset recalled by Zimmer
Zimmer is recalling Zimmer M/L Taper Hip Stem Standard & Extended Offset, Hip Joint Prosthesis, Sizes: 0, 5, distributed nationwide in the US. The recall was initiated on 23 May 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2033-2014
- FDA event ID
- 68390
- Recalling firm
- Zimmer, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 May 2014
- FDA classified
- 10 Jul 2014
- Reported
- 16 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 23 May 2014 | Recall initiated by company | |
| 10 Jul 2014 | Classified by FDA | +48 days |
| 16 Jul 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Zimmer M/L Taper Hip Stem Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes: 5.0, 7.5, 9.0, 10.0, 11.0, 12.5, 13.5, 15.0, 11.25, 17.25, 20.0 & 22.5. The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem, and the instrumentation necessary for proper implantation of these components.
Where it was distributed
Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, China, Europe, India, Japan, Korea and Singapore.
Questions about this recall
Is M/L Taper Hip Stem Standard & Extended Offset, Hip Joint Prosthesis, Sizes: 0, 5, 0, 0, 0 recalled?
Yes. Zimmer recalled M/L Taper Hip Stem Standard & Extended Offset, Hip Joint Prosthesis, Sizes: 0, 5, 0, 0, 0 on 23 May 2014. The recall is Class II and its status is Terminated. Recall number Z-2033-2014.
Why was it recalled?
Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems.
Which lots are affected?
Product ID: 00771100500, Lot #: 60418073, 60814878, 61085493, 61221743, 61576204, 61621459, 61621460, 61801966, 61825644, 61825646, 61851938, 61856660, 61899990, 61909935, 61957246, 61963045, 61967714, 61978787, 62004470, 62071524, 62078280, 62101467, 62143024, 62145543, 62145545, 62179230, 62201751, 62207880, 62213705, 62219904, 62243355, 62309446, 62316375, 62323504, 62329221, 62329222, 62367889, 62386075, 62450636, 62458975, 62472170, 62547040, 62554175, 62564731, 62564732, 62571806, 62615699, 62645213, 62645214, 62652987, 62667687, 77000640 & 77002057. Product ID: 00771100520, Lot #: 7886860, 60371589, 60389984, 60911201, 60993979, 60999893, 61112021, 61585384, 61622518, 61825666, 61825667, 61851924, 61904650, 61951060, 61967705, 62004472, 62004473, 62028785, 62107673, 62130149, 62135097, 62253657, 62253658, 62323506, 62335517, 62410994, 62458977, 62459364, 62472174, 62503201, 62547042, 62564734, 62571808, 62615703, 62636751 & 62636752. Product ID: 00771100600, Lot #: 61067223, 61389192, 61440890, 61613526, 61699183, 61765877, 61772616, 61851919, 61870556, 61919457, 61925455, 61925460, 61978791, 61985997, 61998399, 62004516, 62016452, 62044968, 62125014, 62125015, 62125017, 62145557, 62184296, 62187413, 62213709, 62213710, 62219910, 62219911, 62226002, 62236538, 62323511, 62329225, 62329226, 62380990, 62416655, 62433042, 62459366, 62466091, 62489957, 62489958, 62529364, 62547046, 62554183, 62590697, 62615709, 62645219, 62652995, 62659348 & 77002100. Product ID: 00771100620, Lot #: 7887710, 11006337, 60814885, 60837122, 60876619, 60935819, 61112024, 61304434, 61755954, 61784588, 61904652, 61945405, 61972436, 61998401, 62014575, 62016455, 62130154, 62153643, 62158627, 62201765, 62226004, 62249176, 62253663, 62274955, 62335527, 62356442, 62361541, 62361542, 62416667, 62423066, 62466094, 62489397, 62509251, 62540605, 62564743, 62571809, 62577958, 62586851, 62622688, 62622689 & 62653004. Product ID: 00771100700, Lot #: 61734759, 61837544, 61978805, 62023873, 62059128, 62059132, 62078290, 62096904, 62101438, 62163749, 62169669, 62184307, 62184309, 62201774, 62201775, 62213721, 62226013, 62253668, 62253669, 62282222, 62295527, 62295529, 62302348, 62309461, 62316392, 62316393, 62316394, 62343052, 62350640, 62370012, 62379099, 62380993, 62380998, 62393286, 62393287, 62400751, 62433056, 62478042, 62478043, 62483286, 62484613, 62488308, 62488310, 62488314, 62521917, 62529381, 62540611, 62564748, 62586859, 62608633, 62615717, 62615720, 62630027, 62645229, 62645233, 62653011, 62653012, 62653018 & 62659363. Product ID: 00771100720, Lot #: 60718307, 61329143, 61721071, 61791501, 61904659, 61915121, 61963043, 61978809, 61978811, 61998380, 62004524, 62053392, 62089239, 62089240, 62118159, 62150305, 62163761, 62198235, 62226017, 62231904, 62249178, 62271083, 62282231, 62289028, 62309538, 62316415, 62343058, 62445432, 62540618, 62548498, 62554198, 62571815, 62577960, 62577961, 62601229, 62608641, 62630036 & 62637054. Product ID: 00771100900, Lot #: 61239370, 61690526, 61874323, 61915128, 62004528, 62067023, 62089044, 62089241, 62107690, 62130175, 62135117, 62155221, 62184318, 62198246, 62207908, 62213747, 62213749, 62226020, 62226029, 62243384, 62258677, 62316423, 62323533, 62329246, 62329250, 62329251, 62329252, 62335549, 62350650, 62356461, 62361555, 62370030, 62370033, 62381019, 62386089, 62393301, 62393303, 62438941, 62444848, 62450646, 62452759, 62466109, 62478016, 62488334, 62488335, 62488336, 62489407, 62489414, 62489418, 62521935, 62529418, 62537946, 62547023, 62547026, 62550180, 62560190, 62568620, 62571824, 62571825, 62577965, 62577967, 62577978, 62577980, 62586867, 62590715, 62601238, 62608649, 62608653, 62630041, 62630044, 62636780, 62636785, 62653032, 62653040, 62665781, 62665786, 62665789 & 62667721. Product ID: 00771100920, Lot #: 61253985, 61375619, 61512772, 61585393, 61595710, 61957210, 61998409, 62041869, 62053407, 62067029, 62067030, 62078314, 62096919, 62114320, 62213762, 62226037, 62238364, 62243395, 62243396, 62243397, 62271102, 62309568, 62309570, 62309571, 62323544, 62343077, 62350658, 62356469, 62405422, 62478080, 62509279, 62515355, 62548501, 62550192, 62554218, 62571835, 62594217, 62601245, 62601246, 62608668, 62615738& 62636797. Product ID: 00771101000, Lot #: 61104476, 61365526, 61601704, 61904677, 62041873, 62101423, 62135135, 62141463, 62153669, 62163774, 62179304, 62191529, 62201817, 62213771, 62213774, 62219942, 62243404, 62323548, 62323553, 62323554, 62329274, 62335561, 62342732, 62343085, 62356476, 62356477, 62361572, 62370053, 62370054, 62381042, 62390757, 62405427, 62423111, 62433081, 62438955, 62438956, 62438959, 62452774, 62459016, 62459390, 62465786, 62466117, 62472217, 62484353, 62488357, 62488361, 62488362, 62489436, 62515359, 62515360, 62515361, 62521950, 62540635, 62540637, 62547083, 62550193, 62554223, 62554224, 62554227, 62554229, 62560013, 62564777, 62571840, 62594229, 62615741, 62630061, 62636814, 62645277, 62653052, 62659402, 62665815, 62667739, 62681734, 62681735 & 77002093. Product ID: 00771101020, Lot #: 61259321, 61622528, 61709486, 61784592, 61784593, 61784594, 61900027, 61966482, 61986040, 61998423, 62010415, 62071564, 62089271, 62118208, 62118210, 62145610, 62153681, 62243417, 62243418, 62253695, 62253698, 62265053, 62265055, 62282263, 62302393, 62309591, 62343088, 62350676, 62381050, 62400782, 62416737, 62423118, 62444860, 62445461, 62452781, 62478922, 62484355, 62489996, 62489997, 62515372, 62515373, 62547092, 62554235, 62564783, 62568626, 62594236, 62608688, 62615752, 62630069, 62630070 & 62630071. Product ID: 00771101100, Lot #: 61268897, 61397634, 61900032, 61945457, 61966419, 61992115, 62004546, 62014624, 62014628, 62053423, 62101433, 62114343, 62125039, 62125041, 62135146, 62179323, 62179326, 62198275, 62198276, 62201838, 62207928, 62213792, 62219957, 62246968, 62265060, 62275389, 62275393, 62282266, 62329285, 62329292, 62329294, 62350680, 62350682, 62361590, 62361594, 62370077, 62381077, 62381078, 62405441, 62411081, 62416741, 62416742, 62445470, 62450653, 62452787, 62457896, 62459027, 62466135, 62478022, 62489445, 62496194, 62515376, 62529440, 62540652, 62540653, 62560038, 62571850, 62571852, 62571855, 62578021, 62578023, 62608692, 62615756, 62615757, 62615760, 62622756, 62630077, 62636835, 62645298, 62645302, 62653074, 62653075, 62653076, 62659419, 62665830, 62667755, 62667758, 62667759 & 62681750. Product ID: 00771101120, Lot #: 61550131, 61574108, 61741520, 61812318, 61957205, 61986055, 61998379, 62042654, 62042655, 62089293, 62118226, 62118228, 62243431, 62243432, 62243433, 62246977, 62253712, 62271151, 62274971, 62289089, 62302421, 62302422, 62350689, 62367952, 62386127, 62386128, 62393357, 62393358, 62405456, 62449685, 62459038, 62466138, 62488383, 62496204, 62509307, 62540660, 62571873, 62571876, 62590744, 62622767, 62630086, 62630087, 62653088 & 62665848. Product ID: 00771101200, Lot #: 61239385, 61371703, 61729245, 61813502, 61837571, 61900043, 61925507, 61986064, 61992133, 62053440, 62096940, 62135171, 62153715, 62158688, 62163800, 62191554, 62226077, 62236570, 62238381, 62243440, 62246990, 62265069, 62275406, 62295570, 62316461, 62329304, 62329306, 62329308, 62361602, 62361603, 62361615, 62367955, 62381123, 62381127, 62386135, 62393365, 62393369, 62400796, 62433115, 62433118, 62445482, 62452797, 62459044, 62459405, 62484367, 62484368, 62484373, 62484605, 62484608, 62490022, 62496210, 62503259, 62515398, 62521974, 62540664, 62547111, 62554254, 62564803, 62571887, 62571888, 62571891, 62571892, 62571894, 62571895, 62578035, 62586925, 62594257, 62601289, 62601293, 62608711, 62622775, 62630096, 62645317, 62653098, 62659443, 62665854, 62667766, 62667767, 62667768, 62667770 & 62667773. Product ID: 00771101220, Lot #: 61684022, 61684027, 61792365, 61900048, 61951018, 62014651, 62014653, 62033982, 62033984, 62096947, 62096948, 62141489, 62179386, 62243451, 62243452, 62253735, 62274973, 62275409, 62275410, 62309633, 62335589, 62343112, 62343113, 62367968, 62370096, 62405483, 62411114, 62416762, 62445490, 62452805, 62472250, 62489469, 62490029, 62496221, 62521979, 62521982, 62554264, 62554266, 62560237, 62594272, 62594273, 62601298, 62601299, 62624984, 62653107 & 62665868. Product ID: 00771101300, Lot #: 60832119, 60837119, 61781476, 61910013, 61915163, 61945489, 62033922, 62033923, 62067065, 62085631, 62096953, 62101449, 62179397, 62184368, 62238385, 62243456, 62243458, 62275415, 62275417, 62289109, 62329318, 62329319, 62335595, 62342737, 62361622, 62367971, 62367972, 62370105, 62400816, 62405489, 62409718, 62411121, 62439010, 62439013, 62459056, 62466153, 62478037, 62478038, 62490033, 62496230, 62503267, 62540677, 62550210, 62554268, 62554269, 62554272, 62586943, 62586944, 62586950, 62594276, 62594278, 62608734, 62608736, 62615790, 62636872, 62636875, 62653117, 62653121, 62659457, 62659459, 62659460, 62665873, 62665879, 62667786, 62667788, 62681788 & 62681791. Product ID: 00771101320, Lot #: 61271638, 61375629, 61626112, 61784607, 62010439, 62023916, 62163815, 62179415, 62184374, 62201868, 62226085, 62236571, 62243459, 62249191, 62275419, 62309647, 62316480, 62356539, 62381226, 62386154, 62416773, 62416774, 62427994, 62439017, 62472259, 62484382, 62484383, 62489479, 62489480, 62515430, 62540683, 62554275, 62564824, 62564825, 62564826, 62571923, 62594281, 62594282, 62594284, 62601314, 62615797, 62630117, 62653123 & 62659467. Product ID: 00771101500, Lot #: 60663817, 61371715, 61631812, 61644835, 61825634, 61889909, 61910018, 61925521, 61998368, 62005258, 62067073, 62118255, 62153726, 62169808, 62169809, 62198304, 62231992, 62271178, 62271182, 62275422, 62302450, 62309652, 62329326, 62335599, 62335600, 62343123, 62350720, 62356545, 62367980, 62381243, 62393388, 62393390, 62405497, 62411150, 62416777, 62452825, 62457813, 62457946, 62472264, 62488409, 62488410, 62515434, 62515438, 62540687, 62578062, 62578063, 62586953, 62590762, 62601320, 62608741, 62622803, 62636881, 62653130, 62659472, 62665886 & 62667801. Product ID: 00771101520, Lot #: 60697994, 60852321, 61067270, 61108714, 61468199, 61574112, 61576231, 61622536, 61791516, 61801913, 61894976, 61904711, 61986082, 61998444, 62022573, 62067528, 62071594, 62101463, 62114384, 62153728, 62226091, 62247023, 62271185, 62271186, 62282313, 62289115, 62295593, 62302455, 62350725, 62361630, 62367986, 62423163, 62459068, 62529451, 62540691, 62540692, 62540693, 62571929, 62571930, 62578065, 62586957, 62594293, 62630124, 62630125 & 62653134. Product ID: 00771101600, Lot #: 61559496, 61559497, 61566491, 61595697, 61621514, 61679251, 61765957, 61860920, 61870584, 61951043, 61966461, 61972514, 62004576, 62023921, 62085098, 62089316, 62145634, 62165445, 62198310, 62219999, 62253761, 62253762, 62258730, 62295595, 62316483, 62329333, 62329334, 62335605, 62343130, 62361631, 62370117, 62383290, 62405503, 62416784, 62433153, 62439023, 62445507, 62489494, 62489495, 62496250, 62564837, 62586958, 62594294, 62594295, 62594296, 62601323, 62645341, 62665891 & 62667807. Product ID: 00771101620, Lot #: 105548, 60384735, 61631832, 61673792, 61741538, 61765965, 61919554, 61963019, 61978880, 62010445, 62023923, 62085634, 62153731, 62163827, 62207976, 62247030, 62247031, 62253764, 62265084, 62295598, 62309659, 62329338, 62370120, 62393807, 62400823, 62428010, 62452833, 62521994, 62548508, 62564839, 62571934, 62578070, 62594298, 62601325, 62615807, 62622810, 62636887 & 61145719R. Product ID: 00771101700, Lot #: 60400363, 60609658, 61440906, 61553101, 61553102, 61610075, 61610076, 61712743, 61825720, 61831226, 61870586, 61925530, 61941275, 61941277, 62010446, 62089319, 62130235, 62130237, 62145637, 62145640, 62201881, 62226094, 62253765, 62258732, 62265087, 62302461, 62312431, 62316485, 62329341, 62361633, 62433157, 62452834, 62452835, 62489497, 62564842, 62578071, 62601327, 62615809, 62622813, 62653143, 62653144, 62659485, 62665893 & 60460737R. Product ID: 00771101720, Lot #: 60882289, 61171216, 61553140, 61553141, 61610031, 61690503, 61741528, 61805494, 61831190, 61978881, 61998451, 62004577, 62010447, 62078357, 62141505, 62179426, 62247035, 62253766, 62271191, 62302463, 62312432, 62323612, 62329344, 62343137, 62356553, 62367990, 62439025, 62445509, 62459413, 62489498, 62521997, 62540702, 62547135, 62564844, 62571936, 62578072, 62601328 & 62624988. Product ID: 00771102000, Lot #: 60121420, 60369558, 60968999, 60993940, 61108748, 61559490, 61566487, 61930824, 61986087, 62179431, 62226096, 62329348, 62428017, 62466168, 62540703 & 62659489. Product ID: 00771102020, Lot #: 60876607, 61054560, 61574113, 61791518, 61925533, 61963021, 61966522, 61978883, 62107738, 62184385, 62323616, 62329349, 62416791, 62554287 & 62615813. Product ID: 00771102200, Lot #: 60180253, 60615468, 60852282, 60999884, 61085529, 61527309, 61527315, 61527321, 62243467, 62323618, 62329350, 62484390 & 62540705. Product ID: 00771102220, Lot #: 102401, 60175884, 60199385, 60405478, 61098945, 61582026, 61963052, 62243470, 62323619, 62416792, 62586964, 60092140V, 60952630R & 61098945R.
Where was it sold?
Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, China, Europe, India, Japan, Korea and Singapore.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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