Skip to content
Recall Observatory FDA recall evidence

Device product

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.

Z-1878-2017

March 07, 2017

Class II

Product summary

Firm
Ulrich Medical USA Inc
Event
Event 76740
Status
Terminated
Classification
Class II
Quantity
4,854 plates
Official record key
device-enforcement:Z-1878-2017

Official wording

Reason: Surgical technique was revised to prevent static plate screws blocking mechanisms from disassociating.

Code information: 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

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Surgical technique was revised to prevent static plate screws blocking mechanisms from disassociating.