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U.S. Department of Health and Human Services

Class 2 Device Recall uNion CPS

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  Class 2 Device Recall uNion CPS see related information
Date Initiated by Firm March 07, 2017
Date Posted April 26, 2017
Recall Status1 Terminated 3 on November 30, 2017
Recall Number Z-1878-2017
Recall Event ID 76740
510(K)Number K150666  
Product Classification Appliance, fixation, spinal intervertebral body - Product Code KWQ
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.
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
Recalling Firm/
Manufacturer		 Ulrich Medical USA Inc
18221 Edison Ave
Chesterfield MO 63005-3703
Manufacturer Reason
for Recall		 Surgical technique was revised to prevent static plate screws blocking mechanisms from disassociating.
FDA Determined
Cause 2		 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 in Commerce 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KWQ and Original Applicant = ulrich medical USA
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