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U.S. Department of Health and Human Services

Class 2 Device Recall Anterior Lumbar Interbody Fusion Spine Truss system

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  Class 2 Device Recall Anterior Lumbar Interbody Fusion Spine Truss system see related information
Date Initiated by Firm September 29, 2014
Date Posted December 16, 2014
Recall Status1 Terminated 3 on June 27, 2016
Recall Number Z-0812-2015
Recall Event ID 69662
510(K)Number K112316  
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
Product ASTS-LG1212: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 12 degrees lordosis, 12 mm height and ASTS-LG0612: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 6 degrees lordosis, 12 mm height
Code Information Model ASTS-LG1212 serial numbers: AL23BA064, AL23BA065, AL23BA066, AL23BA067, AL23BA068, AL23BA069, AL23BA070, AL23BA071, AL23BA072, AL23BA073, AL23BA074, AL23BA075, AL23BA076, AL23BA077, AL23BA078, AL23BA079, AL23BA080, AL23BA081, AL23BA082, AL23BA083, AL23BA084, AL23BA085, AL23BA086, AL23BA087, AL23BA088, AL23BA089, AL23BA090, AL23BA091, AL23BA092, AL23BA093  Model ASTS-LG0612 serial numbers: AL13BA050, AL13BA051, AL13BA052, AL13BA053, AL13BA054, AL13BA055, AL13BA056, AL13BA057, AL13BA058, AL13BA059, AL13BA060, AL13BA061, AL13BA062, AL13BA063, AL13BA064, AL13BA065, AL13BA066, AL13BA067, AL13BA068, AL13BA069, AL13BA070, AL13BA071, AL13BA072, AL13BA073, AL13BA074, AL13BA075, AL13BA076
Recalling Firm/
Manufacturer		 4-Web Inc.
6710 Reseach Rd.
Suite #219
Frisco TX 75033
For Additional Information Contact
972-841-6126
Manufacturer Reason
for Recall		 Product is mislabeled.
FDA Determined
Cause 2		 Labeling mix-ups
Action 4Web Medical sent an Urgent Medical Device Recall letter dated November 5, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm does not require any action to be performed by the consignees.The firm plans to label the remaining recalled lot not distributed as , "samples". Please contact 4Web Customer Service for questions and support. Phone: (1-800) 285-7090 Hours: Monday through Friday, 8:00am to 5:00pm Central Standard time.
Quantity in Commerce 35 units
Distribution US Distribution including the states of TX, MT, DC, CA, IL, and MD.
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 = MAX and Original Applicant = 4-WEB, INC.
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