DePuy Custom Implant Devices Packaging: Packaging was not standardized on customs, it was dependant on the geometry of the product Product Usage: Description: Devices meeting the regulatory definition of a custom medical device are those which are provided by prescription at a physician s request to meet a specific patient need and have been exempt from FDA premarket review under the Federal Food, Drug, and Cosmetic Act since 1976. Intended Use: See information contained in the Information for Use for Custom Implant Device (IFU-0902-00-500 rev C)

Detalles del retiro

Fabricante

DePuy Orthopaedics, Inc.

Distribuidor

US Nationwide Distribution - including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, HI, IA, ID, IL, IN, KS, KY, LA, MA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.

Lote

Part Number: 101178997, 101201997, 101201998, 101201999, 101201999, 101214999, 101402998, 101402999, 101403999, 101436996, 101436997, 101466996, 101466997, 101466997, 101466997, 101466997, 101467996, 101467997, 101467997, 101467997, 101467997, 101467998, 101468997, 101468997, 101468997, 101468997, 101468999, 101469996, 101469997, 101469997, 101469997, 101469997, 101469997, 101470996, 101470997, 101470997, 101470997, 101470997, 101470999, 101471997, 101471997, 101471997, 101471997, 101471997, 101472990, 101472991, 101472992, 101472993, 101480961, 101480962, 101480963, 101480964, 101480977, 101480978, 101480983, 101480984, 101480985, 101480988, 101480989, 101480992, 101480993, 101480998, 101480999, 101580988, 101580989, 101580990, 101580991, 101580992, 101580993, 101580994, 101580995, 101811936, 101811936, 101811992, 101811994, 101811996, 101812935, 101812936, 101812993, 101812994, 101812995, 101812996, 101812998, 101813936, 101813936, 101813985, 101813988, 101813989, 101813990, 101813991, 101813992, 101813993, 101813994, 101813995, 101813998, 101814935, 101814935, 101814936, 101814936, 101814989, 101814990, 101814991, 101814992, 101814993, 101814994, 101814994, 101814995, 101814998, 101836862, 101836863, 101836864, 101836865, 101836866, 101836867, 101836868, 101836869, 101836870, 101836871, 101836871, 101836872, 101836873, 101836877, 101836878, 101836879, 101836880, 101836882, 101836883, 101836886, 101836887, 101836888, 101836889, 101836891, 101836892, 101836893, 101836895, 101836896, 101836897, 101836898, 101836899, 101836900, 101836900, 101836900, 101836903, 101836903, 101836903, 101836903, 101836905, 101836905, 101836908, 101836908, 101836908, 101836911, 101836911, 101836911, 101836976, 101836976, 101836977, 101836979, 101836980, 101836981, 101836984, 101836994, 101836996, 101836997, 101836998, 101836999, 101838999, 101839999, 101840972, 101840973, 101840974, 101840975, 101840976, 101840978, 101840979, 101840980, 101840981, 101840991, 101840992, 101840993, 101840994, 101840996, 101840998, 101840999, 101844988, 101844991, 101844992, 101844993, 101844994, 101844997, 101844998, 101844999, 101871936, 101871936, 101871979, 101871980, 101871983, 101871986, 101871987, 101871988, 101871989, 101871990, 101871991, 101871994, 101871995, 101871996, 101871997, 101875936, 101875936, 101875968, 101875969, 101875970, 101875971, 101875973, 101875974, 101875975, 101875976, 101875977, 101875978, 101875980, 101875981, 101875982, 101875984, 101875985, 101875986, 101875987, 101875988, 101875989, 101950999, 101950999, 101950999, 101952999, 101952999, 101959999, 102403999, 102405985, 102405986, 102405988, 102405990, 102405992, 102405994, 102405995, 102405996, 102405997, 102405999, 102407998, 102407999, 102408998, 102408999, 102451998, 102451999, 102452999, 102944993, 102944994, 102946991, 102946991, 102946992, 102950991, 102950992, 102950993, 102950994, 102950995, 102950996, 102952995, 102954994, 102954995, 102956994, 102958995, 102958996, 103144996, 103144997, 103180957, 103180958, 103180959, 103180960, 103180961, 103180963, 103180964, 103180966, 103180967, 103180968, 103180969, 103180970, 103180974, 103180975, 103180976, 103180977, 103180981, 103180983, 103180984, 103180984, 103180985, 103180985, 103180986, 103180986, 103180986, 103180986, 103180987, 103180987, 103180988, 103503999, 103522961, 103522969, 103522972, 103522978, 103522981, 103522991, 103522995, 103522999, 103526999, 103536992, 103536993, 103536995, 103536996, 103536998, 103539995, 103540988, 103540989, 103540994, 103540999, 103602993, 103602996, 103602997, 103643998, 103643999, 103644581, 103644582, 103644972, 103644973, 103644974, 103644975, 103644976, 103644977, 103644979, 103644980, 103644983, 103644985, 103644986, 103644990, 103644991, 103644992, 103644993, 103644994, 103644995, 103644996, 103644997, 103644998, 103644999, 104301998, 104420996, 104420998, 104420999, 104421999, 104424999, 104425997, 104425998, 104425999, 104428994, 104428995, 104428996, 104428997, 104428998, 10442

Clasificación de riesgo

Class II

Área (FDA)

device

País

United States