Pega Medical Inc. recalls Female Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval IM Telescopic System. For ort…

Recall date

April 10, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1546-2015

FDA classification

Class II

Brand / firm

Pega Medical Inc.

Sold / distributed

Worldwide distribution. US in Delaware, Florida, Nebraska, and New York; Australia, Brazil, and United Kingdom.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.