FDAClass IIJuly 16, 2014

Zimmer M/L Taper Reduced Neck Standard & Extended recall

Zimmer M/L Taper Reduced Neck Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes:4, 5, 6, 7.5, 9, 10, 11 & 12.5. The femoral stem component of a…

Why was Zimmer M/L Taper Reduced Neck Standard & Extended recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product ID: 00771100410, Lot #: 60876583, 61098988, 61158127, 61230791, 61542496, 61548105, 61702995, 61729254, 61904645, 61957233, 61963047, 61998392, 62004467, 62067479, 62078278, 62096889, 62107667, 62145541, 62153634, 62184289, 62246880, 62246881, 62253651, 62265027, 62283066, 62316369, 62343031, 62356431, 62361531, 62380986, 62390746, 62445410, 62459360, 62472165, 62495527, 62528301, 62529331, 62529334, 62529335, 62529341, 62577926, 62577929 & 62630007. Product ID: 00771100440, Lot #: 60500974, 60597171, 60824961, 61040634, 61510553, 61601757, 61703092, 61796656, 61870553, 61880423, 61904646, 61963030, 61967702, 62101479, 62135089, 62153635, 62158616, 62176234, 62179221, 62202469, 62239214, 62253653, 62253654, 62275332, 62275333, 62302332, 62309445, 62316374, 62342712, 62405371, 62410988, 62472168, 62521896, 62554173, 62571801, 62577931, 62601210 & 62645212. Product ID: 00771100510, Lot #: 61098989, 61158128, 61595675, 61734799, 61791458, 61870554, 61919455, 61967734, 61985992, 62023864, 62059114, 62085023, 62135094, 62135095, 62143027, 62145548, 62145549, 62145551, 62169649, 62198214, 62238349, 62243359, 62243360, 62302339, 62302341, 62342714, 62367890, 62445414, 62458976, 62459363, 62509237, 62529278, 62529353, 62529362, 62537985, 62540589 & 62554177. Product ID: 00771100540, Lot #: 60659250, 61030264, 61085549, 61098994, 61595699, 61690452, 61749176, 61765962, 61796657, 61845539, 61865602, 61966525, 62004475, 62078283, 62096893, 62130151, 62143029, 62153639, 62158620, 62207884, 62258663, 62271060, 62275338, 62323507, 62335521, 62335522, 62361538, 62445416, 62452735, 62489955, 62503202, 62540593, 62594190 & 62615704. Product ID: 00771100610, Lot #: 61030252, 61416334, 61523437, 61894915, 61894916, 61966499, 62085032, 62114298, 62158626, 62207887, 62219914, 62226003, 62236540, 62238352, 62243369, 62243372, 62243373, 62275343, 62289018, 62302344, 62309453, 62335525, 62356440, 62379097, 62393282, 62405381, 62409688, 62410998, 62411003, 62423064, 62423065, 62445419, 62452741, 62478872, 62478874, 62488298, 62503204, 62528348, 62528349, 62529374, 62529375, 62529377, 62529379, 62550187, 62560161, 62577945, 62615711, 62659356 & 62665753. Product ID: 00771100640, Lot #: 60474089, 60663859, 60911091, 61158157, 61553126, 61631840, 61741531, 61851980, 61860883, 61966531, 62023869, 62059125, 62143033, 62153641, 62187415, 62198221, 62219917, 62219918, 62246894, 62246895, 62265031, 62274956, 62275347, 62343049, 62379098, 62393285, 62405385, 62445421, 62503207, 62521909, 62571810 & 62615713. Product ID: 00771100710, Lot #: 60771280, 61273016, 61499266, 61734803, 61784581, 61812353, 61851927, 62014580, 62053391, 62078295, 62118155, 62141440, 62158635, 62201777, 62231894, 62231895, 62231898, 62243374, 62243375, 62243378, 62275356, 62282228, 62295531, 62302353, 62309465, 62335540, 62343056, 62367904, 62370016, 62381004, 62381005, 62393291, 62400759, 62405394, 62411014, 62416694, 62423075, 62452751, 62458992, 62458994, 62472190, 62488317, 62488318, 62509254, 62509255, 62528381, 62529406, 62537934, 62540614, 62547061, 62547063, 62560179, 62615729, 62645241, 62659370, 62665772, 62681694 & 62681696. Product ID: 00771100740, Lot #: 61550135, 61631841, 61734866, 61772718, 61801919, 61972446, 62023879, 62023881, 62096907, 62135115, 62141445, 62184314, 62198237, 62207901, 62226018, 62231906, 62236548, 62253676, 62289036, 62289037, 62295537, 62309552, 62329235, 62335546, 62343068, 62381009, 62381010, 62393296, 62411019, 62416699, 62416703, 62423083, 62433065, 62433067, 62450644, 62484310, 62488330, 62496123, 62503221, 62540619, 62548499, 62586864, 62594206, 62615732, 62645247, 62645248, 62653028 & 62665780. Product ID: 00771100910, Lot #: 61487760, 61734804, 61851922, 61919486, 61930771, 62004532, 62028813, 62085052, 62114319, 62191514, 62231919, 62243388, 62249182, 62265046, 62295542, 62295546, 62302368, 62316429, 62343075, 62350653, 62350654, 62370035, 62381023, 62405415, 62411029, 62423093, 62433074, 62438948, 62457810, 62457930, 62488343, 62489427, 62509268, 62528392, 62540628, 62540631, 62547073, 62547074, 62554217, 62560009, 62560195, 62577987, 62594212, 62601242, 62608666, 62645268, 62645269 & 62667726. Product ID: 00771100940, Lot #: 61626141, 61805446, 61865594, 62044986, 62135133, 62158651, 62179284, 62226041, 62231939, 62236554, 62246930, 62246931, 62253686, 62253687, 62271105, 62271107, 62295547, 62302374, 62316432, 62323546, 62356470, 62361568, 62379104, 62393315, 62393316, 62400772, 62411062, 62416723, 62416724, 62416726, 62484342, 62489432, 62489984, 62540634, 62554221, 62560204, 62577989, 62590723, 62594226, 62601247, 62608671, 62615739, 62622732, 62645275, 62653046 & 62667736. Product ID: 00771101010, Lot #: 61074843, 61468181, 61755935, 61801882, 62010413, 62107715, 62114333, 62118203, 62236555, 62238371, 62243413, 62243415, 62275380, 62302387, 62316440, 62329279, 62329280, 62350671, 62350673, 62367934, 62393333, 62409705, 62433087, 62433088, 62459020, 62488365, 62496183, 62496185, 62503233, 62515365, 62515366, 62521956, 62529433, 62529437, 62537950, 62560211, 62560212, 62578001, 62578010, 62586893, 62601260, 62622743, 62630063, 62630066, 62645288, 62645289, 62645290, 62662266, 62665820 & 62665822. Product ID: 00771101040, Lot #: 61772722, 61831167, 61851965, 61967716, 62053420, 62063891, 62114337, 62130198, 62130199, 62153683, 62179308, 62198270, 62201832, 62213783, 62246952, 62246953, 62253699, 62271119, 62289076, 62323563, 62343090, 62386116, 62393343, 62423122, 62427973, 62433096, 62433097, 62438975, 62490004, 62490005, 62496188, 62521960, 62550199, 62601265, 62608690, 62622749 & 62645296. Product ID: 00771101110, Lot #: 61510528, 61644836, 61825649, 62014630, 62023896, 62053432, 62089285, 62107718, 62118221, 62130209, 62153694, 62153695, 62169771, 62179331, 62179334, 62231959, 62243427, 62246973, 62275394, 62275395, 62275396, 62282276, 62289085, 62302411, 62309605, 62335576, 62367948, 62381101, 62405446, 62409728, 62445474, 62452544, 62459035, 62466136, 62478927, 62537961, 2594247, 62601276, 62615767, 62630082, 62636841, 62645306, 62653080 & 62667760. Product ID: 00771101140, Lot #: 11003867, 60697997, 61280663, 61298526, 61482862, 61601719, 61814634, 61874350, 61978850, 62096935, 62130212, 62153699, 62201846, 62219967, 62246984, 62258705, 62275399, 62289094, 62316457, 62328717, 62343103, 62370087, 62381110, 62393361, 62416752, 62427976, 62427978, 62452790, 62452791, 62472240, 62478931, 62488385, 62489453, 62489454, 62554247, 62578034, 62594255, 62608710 & 62653089. Product ID: 00771101210, Lot #: 61178805, 61613564, 62023912, 62059189, 62085092, 62101443, 62107720, 62107722, 62118239, 62176269, 62179379, 62179381, 62207950, 62243442, 62243443, 62243445, 62243446, 62253732, 62258711, 62302435, 62309625, 62350699, 62356523, 62370093, 62381159, 62381161, 62405478, 62416759, 62427980, 62433120, 62433121, 62466147, 62472247, 62515406, 62528411, 62540672, 62547114, 62560235, 62560236, 62571906, 62578052, 62586930, 62590752, 62601294, 62608723, 62608724, 62608726, 62630099, 62645322, 62645325, 62653104 & 62665865. Product ID: 00771101240, Lot #: 60911093, 61712776, 61831168, 61930803, 61930804, 61963039, 61966512, 62053451, 62114366, 62135178, 62135179, 62141490, 62201861, 62231982, 62247002, 62249190, 62258714, 62258715, 62271166, 62271167, 62289105, 62316472, 62350706, 62367969, 62381181, 62400811, 62416764, 62416765, 62433134, 62433135, 62459054, 62465797, 62472252, 62515416, 62515417, 62521983, 62571916, 62608731, 62630108, 62653113 & 62653114.

Product
Zimmer M/L Taper Reduced Neck Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes:4, 5, 6, 7.5, 9, 10, 11 & 12.5. The femoral stem component of a…
Recalling firm
Zimmer, Inc.
Quantity
852 units
Distribution
Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, China, Europe, India, Japan, Korea and Singapore.
Recall date
July 16, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls