Reported Apr 16, 2014 · Terminated

Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110; Used in…

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?

  • Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft)
  • Part numberM040-SS-110
  • Used in Implant Catalogue numberFD-040(LS)-SS. orthopedic intramedullary rod
Lot codes and dates
  • Lot #: 130424-15 (only
  • laser marked on the Part Number
    • M040-SS-110)
    • Lot #: 121109-11 &130424-15 [Indicated
  • on the label of the Catalogue NumberFD-040(L)-SS]
Amount recalled
Total of 5 units (2 units in the US and 3 units in Germany)

Where it was sold

Why it was recalled

The Male Components in this lot are made of material with lower strength than manufacturing specifications.

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 Apr 23, 2014 · Data as of Sep 19, 6:49 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.