Pega Medical Inc.: Medical Device Recall in 2015 - (Recall #: Z-1546-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 10, 2015

Date Posted: May 6, 2015

Recall Number: Z-1546-2015

Event ID: 71061

Reason for Recall:

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.

Status: Terminated

Product Quantity: 9 units (5 units in the US and 4 units international)

Code Information:

Lot 290609-01

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated