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Class 2 Device Recall Vilex, Inc., FUZE 10.0 mm x 200 mm, Product FZ100200T25 |
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Date Initiated by Firm |
April 22, 2015 |
Date Posted |
June 08, 2015 |
Recall Status1 |
Terminated 3 on October 30, 2016 |
Recall Number |
Z-1722-2015 |
Recall Event ID |
71344 |
510(K)Number |
K102413
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Product Classification |
Rod, fixation, intramedullary and accessories - Product Code HSB
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Product |
Vilex, Inc., FUZE 10.0 mm x 200 mm, Product # FZ100-200T-25.
Ankle arthrodesis, tibio-talo-calcaneal arthrodesis. |
Code Information |
all codes |
Recalling Firm/ Manufacturer |
Vilex In Tennessee Inc 111 Moffitt Street Mcminnville TN 37110-2235
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For Additional Information Contact |
TBD 931-474-7550
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Manufacturer Reason for Recall |
Incidence of breakage is higher than expected.
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FDA Determined Cause 2 |
Device Design |
Action |
The initial telephone call (4/9/2015) informed the distributor that the product was on hold (not to be used or transferred). The second telephone call (4/29/2015) and letter informed the customer that the product was being removed from market and that the customer was to return the product to the corporate office.
The letter was disseminated on 05/05/2015 to distributors via certified mail. The letter contains the instructions for them to follow, which as summarized are: inventory all products on hand, sign off on inventory sheet, send products back to the corporate office with the identified return number on the shipping container, inform the corporate office that the process has been completed and provide the corporate office with the list of the products returned.
A second letter was disseminated to sales representatives (distributors), surgeons, and hospitals on 05/28/2015. |
Quantity in Commerce |
7 units |
Distribution |
Distributed in the states of MS, MD, PA, and TX. |
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 = HSB and Original Applicant = VILEX, INC.
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