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 modular system that consists of an acetabular component, femoral head, femoral stem, and the instrumentation necessary for proper implantation of these components.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
ā ļø Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Zimmer, Inc.
- Reason for Recall:
- Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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 modular system that consists of an acetabular component, femoral head, femoral stem, and the instrumentation necessary for proper implantation of these components.
Product Codes/Lot Numbers:
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.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2034-2014
Related Recalls
Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-EĀæ Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.
Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-EĀæ Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.
The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.