FDAFDA · Food and drugs·Recall number Z-1608-2024
NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System.
Published May 1, 2024 · Recall initiated: March 28, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer, Inc.
- Distributor
- Worldwide distribution - US Nationwide including the states of AK, AL, CA, FL, GA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI and the countries of Australia, Canada, Japan, Netherlands.
- Lot
- 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, (01)00889024207806(17)281130(10)64226008, (01)00889024207820(17)281130(10)64220651, (01)00889024207790(17)281130(10)64226001, (01)00889024207806(17)281130(10)64226006, (01)00889024207806(17)281130(10)64202119, (01)00889024207790(17)281130(10)64226002, (01)00889024207806(17)281130(10)64202118, (01)00889024207790(17)281231(10)64254389, (01)00889024207806(17)281231(10)64254390, (01)00889024207806(17)281231(10)64226077, (01)00889024207806(17)281231(10)64226078, (01)00889024207806(17)281231(10)64226009, (01)00889024207790(17)281231(10)64226076, (01)00889024207790(17)281231(10)64254387, (01)00889024207790(17)281231(10)64254388, (01)00889024207806(17)281231(10)64261032, (01)00889024207806(17)281231(10)64226129, (01)00889024207820(17)281231(10)64242244, (01)00889024207790(17)281231(10)64254386, (01)00889024207790(17)281231(10)64226076R, (01)00889024207790(17)281231(10)64254386R, (01)00889024207790(17)281231(10)64254387R, (01)00889024207790(17)290131(10)64261030, (01)00889024207790(17)290131(10)64275592, (01)00889024207806(17)290131(10)64275434, (01)00889024207806(17)290131(10)64261033, (01)00889024207806(17)290131(10)64261035, (01)00889024207790(17)290131(10)64261031, (01)00889024207806(17)290131(10)64275593, (01)00889024207790(17)290131(10)64261029, (01)00889024207790(17)290131(10)64275538, (01)00889024207806(17)290131(10)64275540, (01)00889024207820(17)290131(10)64261037, (01)00889024207813(17)290131(10)64261036, (01)00889024207790(17)290131(10)64275537, (01)00889024207806(17)290131(10)64275435, (01)00889024207790(17)290131(10)64275433, (01)00889024207806(17)290131(10)64275541, (01)00889024207813(17)290131(10)64261036R, (01)00889024207790(17)290131(10)64261031R, (01)00889024207806(17)290131(10)64275593R, (01)00889024207790(17)290228(10)64294621, (01)00889024207820(17)290228(10)64306997, (01)00889024207790(17)290228(10)64302414, (01)00889024207790(17)290228(10)64306991, (01)00889024207806(17)290228(10)64302416, (01)00889024207806(17)290228(10)64306994, (01)00889024207806(17)290228(10)64302415, (01)00889024207790(17)290228(10)64275591, (01)00889024207790(17)290228(10)64275432, (01)00889024207806(17)290228(10)64306994R, (01)00889024207806(17)290228(10)64302415R, (01)00889024207790(17)290228(10)64302414R, (01)00889024207806(17)290331(10)64346982, (01)00889024207806(17)290331(10)64334419, (01)00889024207806(17)290331(10)64306995, (01)00889024207806(17)290331(10)64261034, (01)00889024207790(17)290331(10)64306992, (01)00889024207790(17)290331(10)64306993, (01)00889024207813(17)290331(10)64306996, (01)00889024207806(17)290331(10)64334418, (01)00889024207806(17)290331(10)64334420, (01)00889024207790(17)290331(10)64306992R, (01)00889024207790(17)290331(10)64306993R, (01)00889024207813(17)290331(10)64306996R, (01)00889024207790(17)290430(10)64346981, (01)00889024207790(17)290430(10)64367312, (01)00889024207806(17)290430(10)64367404, (01)00889024207806(17)290430(10)64346996, (01)00889024207806(17)290430(10)64367314, (01)00889024207790(17)290430(10)64334415, (01)00889024207
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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