| Class 2 Device Recall Anterior Lumbar Interbody Fusion Spine Truss system |  |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = MAX
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