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U.S. Department of Health and Human Services

Class 2 Device Recall Vilex, Inc., FUZE 10.0 mm x 200 mm, Product FZ100200T25

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  Class 2 Device Recall Vilex, Inc., FUZE 10.0 mm x 200 mm, Product FZ100200T25 see related information
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  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
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
For Additional Information Contact TBD
931-474-7550
Manufacturer Reason
for Recall		 Incidence of breakage is higher than expected.
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
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 = HSB and Original Applicant = VILEX, INC.
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