Ulrich Medical USA Inc: 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.

Recall number

Z-1878-2017

Recalling firm

Ulrich Medical USA Inc

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.

Status

Terminated

Initiated

2017-03-07

Posted

2017-04-26

Terminated

2017-11-30

Reason

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

Root cause

Use error

Action

On March 7, 2017, the recalling firm sent letters by mail informing customers of the field correction along with the updated surgical technique which contains the enhanced cautionary statement. Customers were instructed to destroy older versions of the surgical technique. The letters also contained a link to the recalling firm's website on which the recalling firm posted the current, updated copy of the surgical technique.

Quantity

4,854 plates

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

Lot, serial or model codes

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

510(k) numbers

["K150666"]

PMA numbers

not on file

Product code

KWQ

Firm FEI

3005532635

Firm city

Chesterfield

Firm state

MO

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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