FDA-Device2015-05-06Class II
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.
Pega Medical Inc.
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.
Sold states
Worldwide distribution. US in Delaware, Florida, Nebraska, and New York; Australia, Brazil, and United Kingdom.
Affected count
9 units (5 units in the US and 4 units international)
Manufactured in
1111 Autoroute Chomedy, Laval, Canada
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1546-2015Don't want to check this manually?
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