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 I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- 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.
⚠️ 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 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.
Product Codes/Lot Numbers:
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.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2035-2014
Related Recalls
Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E¿ 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-E¿ 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.