FDAApril 10, 2015device
Female Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval IM Telescopic System. For orthopedic procedures. This instrument is included in the Fassier-Duval IM Telescopic System instrument tray. This instrument is marked with the catalogue number and lot number.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The hexagonal tip of the Female Driver instrument for the Fassier-Duval IM Telescopic System is 0.06 mm under the specifications. This may result in a reduction of the total strength of the instrument, possibly leading to deformation, wear, and tip breakage.
What to do
FDA enforcement status: Terminated
Brands named
pega medicalpega
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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