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
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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 |
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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
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