Pega Medical Inc.: Medical Device Recall in 2014 - (Recall #: Z-1448-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110; Used in Implant Catalogue number: FD-040(LS)-SS. orthopedic intramedullary rod.

Product Classification:

Class II

Date Initiated: February 7, 2014

Date Posted: April 16, 2014

Recall Number: Z-1448-2014

Event ID: 67675

Reason for Recall:

The Male Components in this lot are made of material with lower strength than manufacturing specifications.

Status: Terminated

Product Quantity: Total of 5 units (2 units in the US and 3 units in Germany)

Code Information:

Lot #: 130424-15 (only laser marked on the Part Number: M040-SS-110); Lot #: 121109-11 &130424-15 [Indicated on the label of the Catalogue Number: FD-040(L)-SS].

Distribution Pattern:

Worldwide Distribution - USA Nationwide in the states of Missouri, Texas, and the country of Germany.

Voluntary or Mandated:

Voluntary: Firm initiated