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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76740

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
March 07, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Ulrich Medical USA Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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
Recall number
Z-1878-2017
Initiated
March 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Ulrich Medical USA Inc
Quantity
4,854 plates

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surgical technique was revised to prevent static plate screws blocking mechanisms from disassociating.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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