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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm October 05, 2016
Date Posted November 16, 2016
Recall Status1 Terminated 3 on February 17, 2017
Recall Number Z-0592-2017
Recall Event ID 75337
510(K)Number K133221  
Product Classification Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
Product Arsenal Spinal Fixation System, Set Screw, Part No. 47127
Product Usage: Usage:
The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The Arsenal System consists of a variety of shapes and sizes of rods, screws, hooks, connectors, and bridges that provide temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The screws, hooks, connectors, and bridges are manufactured from surgical grade titanium alloy (Ti-6AI-4V ELI). The rods are available in commercially pure titanium, titanium alloy, and cobalt chrome (CP Ti Grade 4, Ti-6Al-4V ELI, and Co-28Cr-6Mo).
Code Information Lot Numbers 695621  696252  697128  698437  700943  7689801 695622  696253  697129  698438  700944  7689802 695623  696254  697130  698439  700945  7689803 695624  696255  697131  698440  701393  7689804 695625  696256  697520  698441  701394  695626  696257  697521  698442  701395  695627  696258  697522  700611  701396  696124  696558  697523  700612  701397  696125  696574  697524  700613  701398 696126  696575  698433  700614  701399 696127  696576  698434  700615  701400 696128  696577  698435  700941  701401 696251  697127  698436  700942  701851 7878901 7829602 7766302 7766301
Recalling Firm/
Manufacturer		 Alphatec Spine, Inc.
5830 El Camino Real
Carlsbad CA 92008-8816
For Additional Information Contact
760-431-9286
Manufacturer Reason
for Recall		 Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postoperative disengagement from the screw body.
FDA Determined
Cause 2		 Under Investigation by firm
Action Alphatae Spine sent an Urgent Medical Device Recall notification letter dated September 29, 2016 to customers. The letter identified the affected product, problem and the actions to be taken. Customers are instructed to fill out and return the last page of recall letter using one of the methods identified in the letter.
Quantity in Commerce 16,972 units
Distribution Worldwide Distribution - US Nationwide in the countries of Japan, UK, NSW, Spain.
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 = NKB and Original Applicant = ALPHATEC SPINE, INC.
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