Recall Z-1448-2014— Pega Medical Inc.

Name: FDA recall Z-1448-2014
Creator: U.S. Food and Drug Administration
Published: 2014-02-07

Class II · Terminated

Class II FDA medical device recall by Pega Medical Inc., initiated 2014-02-07, terminated 2014-04-23. It names 2 FDA 510(k) clearances: K041393, K020885. Product: 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.. Reason: The Male Components in this lot are made of material with lower strength than manufacturing specifications..

Recalling firm: Pega Medical Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-02-07
Terminated: 2014-04-23
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

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.

Reason for recall

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

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