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

Recall Insight

This FDA Devices action (record #Z-1472-2014) was formally reported on April 30, 2014, with the manufacturer initiating the action on March 5, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Pega Medical Inc. is listed as the recalling firm, operating out of Laval, N/A. Federal records indicate 48 units are affected.

The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Worldwide distribution, USA nationwide, Greece, United Arab Emirates, Peru, Canada, Israel, United Kingdom, France, Germany, Colombia, Mexico, Singapore, Lithuania, Denmark, and Spain.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 12 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.