Device product
Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS. -Duval IM Telescopic System.
Z-1472-2014
Product summary
- Event
- Event 67803
- Status
- Terminated
- Classification
- Class II
- Quantity
- 48
- Official record key
device-enforcement:Z-1472-2014
Official wording
Reason: 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.
Code information: Catalogue Number: FD-040(L)-SS Lot #: 111208-03 and 110808-13 111019-01 and 110808-13 110302-01 and 110808-13
Distribution pattern: Worldwide distribution, USA nationwide, Greece, United Arab Emirates, Peru, Canada, Israel, United Kingdom, France, Germany, Colombia, Mexico, Singapore, Lithuania, Denmark, and Spain.
Derived failure modes
-
Labeling or packaging
label contained the incorrect