Device Recall uNion CPS

  • Model / Serial
    043605, U010751, U010759, U011072, U012021, U012022, U012885, 043606, U010752, U010760, U012023, U012886, 043607, U010753, U010761, U012024, U012887, 043608, U010754, U010762, U012025, U012888, 043609, U010755, U010763, U012026, U012889, 043610, U010756, U010764, U012027, U012890, 043611, U010757, U010765, U012028, U012891, 043612, U010758, U010766, U012029, U012892, 043613, U010149, U010769, U012038, U012541, U012893, 043614, U010148, U010770, U012039, U012894, 043615, U010147, U010771, U012040, U012895, 043616, U010146, U010772, U012041, U012539, U012540, U012896, 043617, U010145, U010773, U012042, U012897, 043618, U010144, U010774, U010963, U012043, U012898, 043619, U010143, U010775, U012044, U012899, 043498, U010142, U012045, U012900, U101776, 043621, U010141, U010777, U012046, U012901, 043622, U010140, U010778, U012047, U012902, 043623, U010193, U010711, U010973, U011066, U012058, U012903, 043624, U010192, U010712, U010972, U011067, U012059, U012650, U012651, U012904, 043625, U010191, U010713, U010971, U011051, U012060, U012905, 043626, U010190, U010714, U010970, U012816, U012906, 043627, U010189, U010715, U012817, U012907, 043628, U010188, U010716, U010969, U012818, U012908, 043629, U010187, U010717, U010968, U012819, U012909, 043630, U010186, U010718, U010967, U012820, U012910, 043631, U010185, U010719, U010966, U012821, U012911, 043632, U010184, U010720, U012822, U012912, 043633, U010183, U010721, U010964, U012823, U012913, 043634, U010206, U011068, U012824, 043635, U010205, U011069, U012825, 043636, U010204, U011070, U012826, 043637, U010203, U011071, U012083, U012827, 043638, U010202, U012084, U012828, 043639, U010201, U011073, U012829, 043640, U010200, U011074, and U012830
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide in the states of: AL, AR, AZ, CA, CT, FL, GA, ID, IL, KS, LA, MO, MS, NY, OH, OK, OR, TN, TX, and WI
  • Product Description
    uNion Cervical Plate System || Product Usage: || The uNion Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to Ti). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Ulrich Medical USA Inc, 18221 Edison Ave, Chesterfield MO 63005-3703
  • Manufacturer Parent Company (2017)
  • Source
    USFDA