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Terminated

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

FDA Recall Z-1472-2014 · Posted 2014-04-18

Recalling FirmPega Medical Inc.
Recall StatusTerminated
Product CodeHSB
Date Initiated2014-03-05
Date Terminated2014-05-19
Product Quantity48

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.

Firm 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.

Root Cause

Error in labeling

Distribution Pattern

Worldwide distribution, USA nationwide, Greece, United Arab Emirates, Peru, Canada, Israel, United Kingdom, France, Germany, Colombia, Mexico, Singapore, Lithuania, Denmark, and Spain.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041393FASSIER-DUVAL TELSCOPIC IM SYSTEMPega Medical, Inc. · 2004-08-17K020885FASSIRE-DUVAL TELESCOPIC IM SYSTEMPega Medical, Inc. · 2003-02-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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