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Pega Medical Inc. recalls Female Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval IM Telescopic System. For ort
Recalled May 6, 2015 · FDA recall Z-1546-2015 · Pega Medical
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. · FDA Class II
Units
9 units (5 units in the US and 4 units international)
Sold at
Worldwide distribution. US in Delaware, Florida, Nebraska, and New York; Australia, Brazil, and United Kingdom.
Description
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.
Product
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.
Manufacturer(s)
Pega Medical Inc.
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →