NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Item No. 00595201501, 00595201502, 00595201505, 00595201506; UDI:(01)00889024207806(17)280731(10)64115713, (01)00889024207806(17)280930(10)64175075, (01)00889024207806(17)280930(10)64175076, (01)00889024207790(17)280930(10)64175073, (01)00889024207806(17)280930(10)64138317, (01)00889024207790(17)281031(10)64175074, (01)00889024207790(17)281031(10)64194991, (01)00889024207790(17)281031(10)64202116, (01)00889024207806(17)281031(10)64178998, (01)00889024207813(17)281031(10)64179054, (01)00889024207790(17)281031(10)64202117, (01)00889024207813(17)281031(10)64179043, (01)00889024207813(17)281031(10)64194989, (01)00889024207790(17)281031(10)64178996, (01)00889024207790(17)281031(10)64178997, (01)00889024207790(17)281031(10)64179023, (01)00889024207820(17)281031(10)64178999, (01)00889024207813(17)281031(10)64179043R, (01)00889024207813(17)281031(10)64194989R, (01)00889024207790(17)281130(10)64202115, (01)00889024207790(17)281130(10)64226003, 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(01)00889024207806(17)331107(10)66324859, (01)00889024207790(17)331111(10)66324849, (01)00889024207790(17)331126(10)66324846, (01)00889024207806(17)331127(10)66324856, (01)00889024207790(17)331201(10)66324852, (01)00889024207806(17)331203(10)66324862, (01)00889024207790(17)331208(10)66378806, (01)00889024207790(17)331212(10)66364015, (01)00889024207820(17)340110(10)66378834, (01)00889024207806(17)340113(10)66364020; Lot Code: 64115713, 64175075, 64175076, 64175073, 64138317, 64175074, 64194991, 64202116, 64178998, 64179054, 64202117, 64179043, 64194989, 64178996, 64178997, 64179023, 64178999, 64179043R, 64194989R, 64202115, 64226003, 64226007, 64226008, 64220651, 64226001, 64226006, 64202119, 64226002, 64202118, 64254389, 64254390, 64226077, 64226078, 64226009, 64226076, 64254387, 64254388, 64261032, 64226129, 64242244, 64254386, 64226076R, 64254386R, 64254387R, 64261030, 64275592, 64275434, 64261033, 64261035, 64261031, 64275593, 64261029, 64275538, 64275540, 64261037, 64261036, 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- 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:
- Out of specification violation of devices that results in a gap existing within the fixture that presses the fiber metal pad to the substrate, causing the pad to not fully bond to the substrate.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System.
Product Codes/Lot Numbers:
Item No. 00595201501, 00595201502, 00595201505, 00595201506; UDI:(01)00889024207806(17)280731(10)64115713, (01)00889024207806(17)280930(10)64175075, (01)00889024207806(17)280930(10)64175076, (01)00889024207790(17)280930(10)64175073, (01)00889024207806(17)280930(10)64138317, (01)00889024207790(17)281031(10)64175074, (01)00889024207790(17)281031(10)64194991, (01)00889024207790(17)281031(10)64202116, (01)00889024207806(17)281031(10)64178998, (01)00889024207813(17)281031(10)64179054, (01)00889024207790(17)281031(10)64202117, (01)00889024207813(17)281031(10)64179043, (01)00889024207813(17)281031(10)64194989, (01)00889024207790(17)281031(10)64178996, (01)00889024207790(17)281031(10)64178997, (01)00889024207790(17)281031(10)64179023, (01)00889024207820(17)281031(10)64178999, (01)00889024207813(17)281031(10)64179043R, (01)00889024207813(17)281031(10)64194989R, (01)00889024207790(17)281130(10)64202115, (01)00889024207790(17)281130(10)64226003, (01)00889024207806(17)281130(10)64226007, 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(01)00889024207790(17)331111(10)66324849, (01)00889024207790(17)331126(10)66324846, (01)00889024207806(17)331127(10)66324856, (01)00889024207790(17)331201(10)66324852, (01)00889024207806(17)331203(10)66324862, (01)00889024207790(17)331208(10)66378806, (01)00889024207790(17)331212(10)66364015, (01)00889024207820(17)340110(10)66378834, (01)00889024207806(17)340113(10)66364020; Lot Code: 64115713, 64175075, 64175076, 64175073, 64138317, 64175074, 64194991, 64202116, 64178998, 64179054, 64202117, 64179043, 64194989, 64178996, 64178997, 64179023, 64178999, 64179043R, 64194989R, 64202115, 64226003, 64226007, 64226008, 64220651, 64226001, 64226006, 64202119, 64226002, 64202118, 64254389, 64254390, 64226077, 64226078, 64226009, 64226076, 64254387, 64254388, 64261032, 64226129, 64242244, 64254386, 64226076R, 64254386R, 64254387R, 64261030, 64275592, 64275434, 64261033, 64261035, 64261031, 64275593, 64261029, 64275538, 64275540, 64261037, 64261036, 64275537, 64275435, 64275433, 64275541, 64261036R, 64261031R, 64275593R, 64294621, 64306997, 64302414, 64306991, 64302416, 64306994, 64302415, 64275591, 64275432, 64306994R, 64302415R, 64302414R, 64346982, 64334419, 64306995, 64261034, 64306992, 64306993, 64306996, 64334418, 64334420, 64306992R, 64306993R, 64306996R, 64346981, 64367312, 64367404, 64346996, 64367314, 64334415, 64334416, 64346995, 64367311, 64367311R, 64367403, 64367313, 64408081, 64367316, 64367318, 64400527, 64406831, 64406829, 64400526, 64406828, 64406830, 64406827, 64442403, 64414262, 64442404, 64442405, 64442407, 64442406, 64442407R, 64442408, 64480241, 64500130, 77009443, 64480265, 64540911, 64480242, 64480243, 64480264, 64480244, 64575335, 64575349, 64575359, 64575350, 64540917, 64575340, 64579745, 64579720, 64597631, 64597589, 64597633, 64597617, 64597632, 64675420, 64597618, 64675429, 64675430, 64699333, 64675440, 64675436, 64699359, 64699328, 64699369, 64699370, 64699352, 64675448, 64699392, 64699383, 64699391, 11024790, 64699406, 64808827, 64808820, 64825317, 64808824, 64808826, 64808835, 64827305, 64827304, 64808843, 64808850, 64808849, 64808858, 64808839, 64808866, 64808878, 64808873, 64808879, 64808887, 64808893, 64928262, 64928265, 64928264, 64827306, 64928273, 64928272, 64928279, 64928281, 64928290, 64928292, 64928301, 64928310, 64928316, 64928312, 64928325, 64928326, 64928337, 64928336, 64928345, 65038141, 65038133, 65038134, 65038135, 65038145, 65038144, 65038149, 65038142, 65038150, 65038154, 65038158, 65038140, 65038159, 65038162, 65038168, 65038169, 65038170, 65038171, 65038178, 65038182, 65038179, 65038137, 65038138, 65038139, 65038136, 65081582, 65081588, 65081597, 65117638, 65117642, 65117654, 65203277, 65203273, 65117670, 65117659, 65203270, 65203271, 65203283, 65203279, 65117658, 65117669, 65117682, 65346422, 65356469, 65356467, 65384861, 65397002, 65403274, 65410849, 65416980, 65416982, 65424129, 65439425, 65439423, 65439427, 65447051, 65447049, 65460281, 65474103, 65486266, 65521956, 65559114, 65559112, 65573605, 65573604, 65602373, 65594083, 65602376, 65611118, 65696513, 65617532, 65625154, 65751453, 65738055, 66005557, 66005559, 11025242, 66005554, 66324843, 66324859, 66324849, 66324846, 66324856, 66324852, 66324862, 66378806, 66364015, 66378834, 66364020.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1608-2024
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.