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Zimmer M/L Taper Hip Stem Standard & Extended Offset, HIP… recallZ-2033-2014 · Zimmer, Inc. · initiated May 23, 2014

Class II Terminated All recalls posted in July 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Zimmer, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems.

FDA root cause category: Packaging

What the company is doing

Zimmer sent an Medical Device Recall Letter on June 4, 2014, to their Distributors. On June 9, 2014, Zimmer sent Medical Device Recall Letters to the physicians. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed: 1. Locate all products from the affected lots and quarantine them immediately, if not previously done so per the May 23, 2014 Notice of Suspension of Loaner Pool. 2. Confirm the physical count of all affected product in loaner pool in your territory and complete the Confirmation of Loaner Pool Inventory and Return Certification Form (Attachment 2), and email a completed copy of Attachment 2 to [email protected]. 3. Return the recalled product along with the completed Confirmation of Loaner Pool Inventory and Return Certification Form (Attachment 2). 4. Identify additional customers that may have used this product in the past 12 months by completing the spreadsheet template provided to you via email or confirm that Zimmer has identified all current customers in your territory. 5. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST.

Recall details

Recall number
Z-2033-2014
Recall class
Class II
Status
Terminated
Initiated by the company
May 23, 2014
Posted by the FDA
Jul 10, 2014
Recalling firm
Zimmer, Inc.
Quantity
1487 units
Product code
LPH
FDA submissions
K032726
Distribution
Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, China, Europe, India, Japan, Korea and Singapore.

Product description

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.

Code information (models, lots, serial numbers)

Show the full code information (13k characters)

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.

Other devices under the same FDA submission

27 devices cleared under K032726 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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