FDAFDA · Alimentos y medicamentos·N.º oficial Z-1608-2024
NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System.
Publicado el 1 de mayo de 2024 · Inicio del retiro: 28 de marzo de 2024
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Zimmer, Inc.
- Distribuidor
- 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.
- Lote
- 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
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
¿Vendes productos como este?
Recalert vigila todo tu catálogo contra retiros como este, automáticamente.