Recall Z-1472-2014 ยท HSB Rod, Fixation, Intramedullary And Accessories
Pega Medical Inc.
Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS. -Duval IM Telescopic System.
| Date | Apr 18, 2014 (initiated Mar 5, 2014) |
| Status | Terminated |
| 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. |
| Root cause | 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 | 48 |
| Distribution | Worldwide distribution, USA nationwide, Greece, United Arab Emirates, Peru, Canada, Israel, United Kingdom, France, Germany, Colombia, Mexico, Singapore, Lithuania, Denmark, and Spain. |
| FDA record | Open on fda.gov |