Reported Apr 30, 2014 · Terminated

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

Pega Medical Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Pega Medical Inc. · 1111 Autoroute Chomedy · Laval, N/A · N/A

Is this the product you have?

  • Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS. -Duval IM Telescopic System.
Lot codes and dates
  • Catalogue NumberFD-040(L)-SS Lot #: 111208-03 and 110808-13 111019-01 and 110808-13 110302-01 and 110808-13
Amount recalled
48

Where it was sold

  • Nationwide

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 19, 2014 · Data as of Sep 19, 4:46 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.