Z-1472-2014Class II

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

Name: Z-1472-2014 Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS...
Creator: Pega Medical Inc.
Published: 2014-03-05
License: https://open.fda.gov/license/

Orthopediatrics Canada ULC / initiated 2014-03-05 / Terminated / root cause: labeling and UDI

FDA source

Pega Medical Inc. began a recall of Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS. -Duval IM Telescopic System on 2014-03-05. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1472-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-05
Posted: 2014-04-18
Terminated: 2014-05-19
Recalling firm: Orthopediatrics Canada ULC
Product: Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS. -Duval IM Telescopic System.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
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.
Root cause tag: labeling and UDI
FDA 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 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.
Product codes and lots: Catalogue Number: FD-040(L)-SS Lot #: 111208-03 and 110808-13 111019-01 and 110808-13 110302-01 and 110808-13

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1472-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1472-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-30	2014-04-18

Product code HSB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)