PlainRecalls
FDA Devices Moderate Class II Terminated

Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS. -Duval IM Telescopic System.

Reported: April 30, 2014 Initiated: March 5, 2014 #Z-1472-2014

Product Description

Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS. -Duval IM Telescopic System.

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.

Details

Recalling Firm
Pega Medical Inc.
Units Affected
48
Distribution
Worldwide distribution, USA nationwide, Greece, United Arab Emirates, Peru, Canada, Israel, United Kingdom, France, Germany, Colombia, Mexico, Singapore, Lithuania, Denmark, and Spain.
Location
Laval, N/A

Frequently Asked Questions

What product was recalled?
Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS. -Duval IM Telescopic System.. Recalled by Pega Medical Inc.. Units affected: 48.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 30, 2014. Severity: Moderate. Recall number: Z-1472-2014.