Devices

Device Recall SROM Noiles Rotating Hinge Femur with Pin

  • Modelo / Serial
    Both Right and Left 102935, 110571, 114271, 114274, 114277, 128477, 132946, 142857, 156158, 162498, 162499, 162500, 172191, 172194, 193664, 193668, 217297, 224704, 229189, 229192, 229195, 229196, 236454, 236463, 236466, 241379, 249713, 249714, 249715, 254742, 254743, 260549, 260552, 269715, 269717, 278454, 278456, 283005, 283006, 283007, 291037, 291038, 291039, 295391, 302819, 306516, 306517, 314828, 314831, 314832, 317759, 317761, 317765, 317769, 317770, 317772, 329335, 338170, 338171, 338173, 338176, 346442, 354609, 354614, 360644, 360645, 360646, 360647, 366437, 366439, 366440, 373257, 373258, 378654, 378655, 378657, 378660, 385029, 385031, 385033, 385034, 392028, 392029, 392032, 400543, 400544, 402441, 403009, 403012, 409586, 414761, 414762, 414763, 414764, 414765, 414766, 414767, 430493, 430494, 430495, 430496, 430498, 438592, 438593, 438594, 438595, 438596, 438597, 438598, 438599, 448539, 452452, 453170, 453171, 453172, 456749, 456751, 456752, 456753, 456754, 470494, 470496, 470503, 470504, D51B54, D51B64, D51B84, D51B94, DN5ET4, DY5EP4, E4EGG4, E5WCF4, E6CFK4, FD6G14, FE2DP4, FL8AM4
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to Canada, Australia, Austria, China, Czech Republic, Denmark, Dubai / UAE, Estonia, France, Germany, Hungary, Iberia, India, Ireland, Israel, Italy, Malaysia, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Russia, Singapore, Slovenia, Spain, South Africa, Sweden, Switzerland, Turkey, United Kingdom, and Vietnam.
  • Descripción del producto
    REF 623421 RS-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right , X-Small, Sterile R || Qty 1 || The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time.
  • Manufacturer
    DePuy Orthopaedics, Inc.
  • 1 Event

Fabricante

DePuy Orthopaedics, Inc.
  • Dirección del fabricante
    DePuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA

5 dispositivos con un nombre similar

Más información acerca de la data acá

Device Recall SROM Noiles Rotating Hinge Femur with Pin
  • Modelo / Serial
    249649, 102928, 102929, 109312, 128472, 142839, 142840, 142841, 162485, 196050, 196051, 196052, 211382, 211387, 213581, 227387, 231687, 249644, 249647, 269701, 269702, 288346, 298769, 298770, 298772, 306503, 306505, 329328, 338142, 346434, 354575, 360633, 360634, 366429, 366430, 373254, 378641, 378642, 378644, 402462, 403004, 403005, 403007, 403008, 421300, 438246, 438247, 438248, 438249, 452447, 456738, 456740, 466369, 466370, 466371, 058401LA, 137401LA, D2WBG4, D37FW4, D37GP4, DV6LY4, DY5EC4, DY5ED4, E1VHM4, E3SDW4, E6CE94, E82E14, EA8EH4, EF5BS4, EJ6G34, EW6HT4, FJ3D14, FJ3D24, and FJ3DY4
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to Canada, Australia, Austria, China, Czech Republic, Denmark, Dubai / UAE, Estonia, France, Germany, Hungary, Iberia, India, Ireland, Israel, Italy, Malaysia, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Russia, Singapore, Slovenia, Spain, South Africa, Sweden, Switzerland, Turkey, United Kingdom, and Vietnam.
  • Descripción del producto
    REF 623401 L || S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, medium, Sterile R || Qty 1 || The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time.
  • Manufacturer
    DePuy Orthopaedics, Inc.
Device Recall SROM Noiles Rotating Hinge Femur with Pin
  • Modelo / Serial
    102325, 102326, 109315, 109316, 120082, 128475, 142843, 142845, 162487, 197812, 197813, 197814, 207924, 222654, 222657, 231689, 231690, 236435, 236442, 261758, 265711, 265714, 265715, 265717, 282997, 285154, 285155, 289096, 302804, 302807, 302808, 317754, 317755, 338154, 338155, 338157, 354580, 360635, 360636, 366432, 378645, 378647, 378650, 400505, 400506, 402456, 414735, 414736, 414737, 430481, 451998, 451999, 452448, 456741, 456742, 456743, 472193, 472194, 472195, 197401RA, D2WBJ4, DY5EF4, E3SD14, E49HN4, EW6HW4, EW6HX4, and FK8CR4
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to Canada, Australia, Austria, China, Czech Republic, Denmark, Dubai / UAE, Estonia, France, Germany, Hungary, Iberia, India, Ireland, Israel, Italy, Malaysia, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Russia, Singapore, Slovenia, Spain, South Africa, Sweden, Switzerland, Turkey, United Kingdom, and Vietnam.
  • Descripción del producto
    REF 623401 R, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Medium, Sterile R || Qty 1 || The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time.
  • Manufacturer
    DePuy Orthopaedics, Inc.
Device Recall SROM Noiles Rotating Hinge Femur with Pin
  • Modelo / Serial
    E1VHS4, 430482, 338164, 373256, 395802, 409578, 448220, 409582, 238688, 430483, 306508, 329330, 264451, 448222, 216275, 373255, 346439, 409580, 338165, 250929, 360638, D65FJ4, 216277, 395804, EJ7F14, 254740, 302815, FF8DW4, 314821, 464642, 338166, FA4FP4, FA4FT4, 238411LC, 464643, 278448, 409579, 464640, 395803, 088411LA, 308248, FF8DX4, 196411LA, 448227, C1VCE4, 402352, 346437, 366433, 238687, 172188, 329332, 250931, 464641, 216274, 302813, 295384, 264453, 337411LA, 120084, 236445, 289043, 329331, 308247, and 395806
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to Canada, Australia, Austria, China, Czech Republic, Denmark, Dubai / UAE, Estonia, France, Germany, Hungary, Iberia, India, Ireland, Israel, Italy, Malaysia, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Russia, Singapore, Slovenia, Spain, South Africa, Sweden, Switzerland, Turkey, United Kingdom, and Vietnam.
  • Descripción del producto
    REF 623411 L, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, Small, Sterile R || Qty 1 || The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time.
  • Manufacturer
    DePuy Orthopaedics, Inc.
Device Recall SROM Noiles Rotating Hinge Femur with Pin
  • Modelo / Serial
    102932, 102933, 102934, 120086, 142854, 156155, 156156, 156157, 162493, 172189, 181460, 181462, 193663, 231692, 231695, 236448, 241369, 241371, 246794, 261763, 269712, 278450, 278451, 278452, 282999, 283000, 283001, 291033, 291034, 302817, 306511, 306512, 306513, 317757, 317758, 329334, 338167, 338168, 346440, 360639, 360640, 360641, 366434, 366435, 366436, 378652, 392023, 400513, 400514, 406837, 409583, 412683, 414752, 430490, 430491, 430492, 448537, 456744, 456745, 456747, 456748, 464644, 464646, 464647, 266411RA, 467411RB, D1TAN4, E1VHX4, E4EGB4, E73H74, E82E74, E82E84, E82E94, EN7JC4, EW6H24, FK8GP4, and FL1VH4.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to Canada, Australia, Austria, China, Czech Republic, Denmark, Dubai / UAE, Estonia, France, Germany, Hungary, Iberia, India, Ireland, Israel, Italy, Malaysia, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Russia, Singapore, Slovenia, Spain, South Africa, Sweden, Switzerland, Turkey, United Kingdom, and Vietnam.
  • Descripción del producto
    REF 623411 R S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Small, Sterile R || Qty 1 || The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time.
  • Manufacturer
    DePuy Orthopaedics, Inc.
Device Recall SROM Noiles Rotating Hinge Femur with Pin
  • Modelo / Serial
    Both left and Right 102935, 110571, 114271, 114274, 114277, 128477, 132946, 142857, 156158, 162498, 162499, 162500, 172191, 172194, 193664, 193668, 217297, 224704, 229189, 229192, 229195, 229196, 236454, 236463, 236466, 241379, 249713, 249714, 249715, 254742, 254743, 260549, 260552, 269715, 269717, 278454, 278456, 283005, 283006, 283007, 291037, 291038, 291039, 295391, 302819, 306516, 306517, 314828, 314831, 314832, 317759, 317761, 317765, 317769, 317770, 317772, 329335, 338170, 338171, 338173, 338176, 346442, 354609, 354614, 360644, 360645, 360646, 360647, 366437, 366439, 366440, 373257, 373258, 378654, 378655, 378657, 378660, 385029, 385031, 385033, 385034, 392028, 392029, 392032, 400543, 400544, 402441, 403009, 403012, 409586, 414761, 414762, 414763, 414764, 414765, 414766, 414767, 430493, 430494, 430495, 430496, 430498, 438592, 438593, 438594, 438595, 438596, 438597, 438598, 438599, 448539, 452452, 453170, 453171, 453172, 456749, 456751, 456752, 456753, 456754, 470494, 470496, 470503, 470504, D51B54, D51B64, D51B84, D51B94, DN5ET4, DY5EP4, E4EGG4, E5WCF4, E6CFK4, FD6G14, FE2DP4, FL8AM4
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to Canada, Australia, Austria, China, Czech Republic, Denmark, Dubai / UAE, Estonia, France, Germany, Hungary, Iberia, India, Ireland, Israel, Italy, Malaysia, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Russia, Singapore, Slovenia, Spain, South Africa, Sweden, Switzerland, Turkey, United Kingdom, and Vietnam.
  • Descripción del producto
    REF 623421 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left , X-Small, Sterile R || Qty 1 || The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time.
  • Manufacturer
    DePuy Orthopaedics, Inc.