Zimmer, Inc.: Medical Device Recall in 2014 - (Recall #: Z-2035-2014)

Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology, 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 II

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

Product ID: 00771300500, Lot #: 61694618, 61743290, 61812682, 61845568, 61845569, 61972395, 61972396, 61978915, 62030113, 62044919, 62118875, 62134957, 62163650, 62169474, 62225879, 62225880, 62354721, 62418036, 62418040, 62460390, 62478289, 62586736 & 62687940. Product ID: 00771300600, Lot #: 60958672, 61468347, 61768416, 61945209, 62071403, 62179055, 62198165, 62238299, 62243210, 62361446, 62422692, 62425093, 62425097, 62430583, 62460385, 62478293, 62484262, 62528055, 62554084, 62616549, 62667448, 62681512 & 77002699. Product ID: 00771300700, Lot #: 61856468, 61950857, 61985935, 62118858, 62153527, 62163657, 62247195, 62275860, 62361448, 62361449, 62414878, 62414882, 62418044, 62454089, 62454091, 62454093, 62489358, 62521396, 62528063, 62554092, 62578361, 62614850, 62652926, 62659300 & 62681516. Product ID: 00771300900, Lot #: 61548886, 62225891, 62282073, 62335405, 62335409, 62356148, 62361455, 62367790, 62414880, 62417690, 62472139, 62484266, 62489363, 62496069, 62521565, 62530628, 62540514, 62554103, 62564692, 62578368, 62578370, 62652933, 62667455 & 62700933. Product ID: 00771301000, Lot #: 61356738, 61796994, 61850999, 62030070, 62124949, 62169497, 62198185, 62253484, 62288848, 62342743, 62342963, 62342967, 62367798, 62367799, 62443121, 62443123, 62503161, 62560129, 62564694, 62564698, 62578377, 62594161, 62652941, 62652942, 62667463, 62694065 & 77003232. Product ID: 00771301100, Lot #: 61576325, 61786474, 61909829, 61950874, 62066981, 62163668, 62201722, 62207778, 62253492, 62417698, 62428479, 62432955, 62432959, 62450085, 62496079, 62521571, 62521572, 62540529, 62554121, 62564702, 62578385, 62616557, 62647175, 62647178, 62659302, 62667466 & 62667469. Product ID: 00771301200, Lot #: 60898841, 61300903, 61409710, 62030078, 62041818, 62163670, 62198191, 62207784, 62253638, 62270938, 62282101, 62356206, 62418052, 62428484, 62428488, 62432966, 62478323, 62484283, 62496086, 62503168, 62521407, 62546967, 62546968, 62546975, 62564705, 62578401, 62659306 & 62687964. Product ID: 00771301300, Lot #: 61542773, 61909835, 61978950, 61998346, 62030103, 62059101, 62066988, 62176190, 62213560, 62219796, 62243241, 62350591, 62418054, 62420827, 62425109, 62484286, 62489381, 62521416, 62521419, 62578404, 62614869, 62622958 & 62681546. Product ID: 00771301500, Lot #: 61613909, 61743314, 61894833, 61925319, 61967638, 62014552, 62014553, 62071435, 62130041, 62213563, 62225910, 62253643, 62350594, 62361478, 62420834, 62594177, 62622960 & 62652963. Product ID: 00771301600, Lot #: 60803338, 61735132, 61781830, 61796999, 61837511, 61945229, 61945232, 61966387, 61991587, 62030114, 62041829, 62114219, 62153556, 62246579, 62420836, 62432974, 62432975, 62432976 & 77002653. Product ID: 00771301700, Lot #: 11002955, 60815998, 60819830, 60845838, 61719863, 61741697, 61894835, 62010559, 62078152, 62101365, 62124961, 62207790, 62219802, 62253646, 62361479, 62478333, 62521429, 62564713, 62578411 & 60841248R. Product ID: 00771302000, Lot #: 60617023, 60940201, 61326522, 61576337, 61613958, 61729730, 61985982, 62078154, 62225912, 62295421, 62356231 & 62478335. Product ID: 00771302200, Lot #: 11001594, 11001595, 11001596, 11003622, 60617024, 60837142, 60940196, 61040881, 61081253 & 62342976.

Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, China, Europe, India, Japan, Korea and Singapore.

Voluntary: Firm initiated