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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer M/L Taper Reduced Neck Standard & Extended Offset,

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 Class 2 Device Recall Zimmer M/L Taper Reduced Neck Standard & Extended Offset,see related information
Date Initiated by FirmMay 23, 2014
Date PostedJuly 10, 2014
Recall Status1 Terminated 3 on March 06, 2015
Recall NumberZ-2034-2014
Recall Event ID 68390
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
ProductZimmer 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 modular system that consists of an acetabular component, femoral head, femoral stem, and the instrumentation necessary for proper implantation of these components.
Code Information 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.
Recalling Firm/
Manufacturer
Zimmer, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information ContactConsumer Relations Call Center
800-613-6131
Manufacturer Reason
for Recall
Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems.
FDA Determined
Cause 2
Packaging
ActionZimmer 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 corporatequality.postmarket@zimmer.com. 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.
Quantity in Commerce852 units
DistributionWorldwide Distribution - USA (nationwide) and the countries of Australia, Canada, China, Europe, India, Japan, Korea and Singapore.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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