Recall Z-1472-2014— Pega Medical Inc.

Name: FDA recall Z-1472-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-05

Class II · Terminated

Class II FDA medical device recall by Pega Medical Inc., initiated 2014-03-05, terminated 2014-05-19. It names 2 FDA 510(k) clearances: K041393, K020885. Product: Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS. -Duval IM Telescopic System.. Reason: The outer package label contained the incorrect length of the device. There is a label on the outer package and an additional label on the product contained in the package..

Recalling firm: Pega Medical Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-03-05
Terminated: 2014-05-19
Firm location: Laval, N/A, Canada

510(k) clearances named in this recall

2 on FDA's record

K041393 — FASSIER-DUVAL TELSCOPIC IM SYSTEMPega Medical, Inc.·cleared 2004-08-17
K020885 — FASSIRE-DUVAL TELESCOPIC IM SYSTEMPega Medical, Inc.·cleared 2003-02-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS. -Duval IM Telescopic System.

Reason for recall

The outer package label contained the incorrect length of the device. There is a label on the outer package and an additional label on the product contained in the package.

Data sourced from openFDA. This site is unofficial and independent of the FDA.