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U.S. Department of Health and Human Services

Class 2 Device Recall FassierDuval IM Telescopic System

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  Class 2 Device Recall FassierDuval IM Telescopic System see related information
Date Initiated by Firm March 05, 2014
Date Posted April 18, 2014
Recall Status1 Terminated 3 on May 19, 2014
Recall Number Z-1472-2014
Recall Event ID 67803
510(K)Number K020885  K041393  
Product Classification ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES - Product Code HSB
Product Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS.
























-Duval IM Telescopic System.
Code Information Catalogue Number: FD-040(L)-SS Lot #: 111208-03 and 110808-13  111019-01 and 110808-13  110302-01 and 110808-13
Recalling Firm/
Manufacturer		 Pega Medical Inc.
1111 Autoroute Chomedy
Laval Canada
For Additional Information Contact Enrique Garcia
450-688-5144
Manufacturer Reason
for Recall		 The outer package label contained the incorrect length of the device. There is a label on the outer package and an additional label on the product contained in the package.
FDA Determined
Cause 2		 Error in labeling
Action There is an error on the outside label of the implant. The length was mistaken on the label. It was indicated 245mm instead of 338mm. It has to be clarified that the Fassier-Duval implant is provided with two labels, one that is outside the tube used for packaging and one inside the tube.
Quantity in Commerce 48
Distribution Worldwide distribution, USA nationwide, Greece, United Arab Emirates, Peru, Canada, Israel, United Kingdom, France, Germany, Colombia, Mexico, Singapore, Lithuania, Denmark, and 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 = HSB and Original Applicant = PEGA MEDICAL INC.
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