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FASSIER-DUVAL TELESCOPIC IM SYSTEM, product family

by Orthopediatrics Canada ULC 36 variants Basic UDI-DI 7540194FD-PEGLE

Shared by every variant

Manufacturer
Orthopediatrics Canada ULC(36)
Basic UDI-DI
7540194FD-PEGLE
Risk class
Class II
Legislation
—
EMDN category
—
Market status
36 on the market
Official record
EUDAMED public site — Open the EUDAMED public site, choose Devices, and search for the Basic UDI-DI 7540194FD-PEGLE.

Recalls

5 recalls · 1 ongoing · FDA

  • Z-2941-2024 Class II · ongoing · 4 Jul 2024
    During the assembly of the FRT250 cartridge assembly, an incorrect component was used. Specifically, the FRT240-HEX (2) was used instead of the FRT250-HEX.
  • Z-1546-2015 Class II · terminated · 10 Apr 2015
    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.
  • Z-1472-2014 Class II · terminated · 5 Mar 2014
    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.
  • Z-1448-2014 Class II · terminated · 7 Feb 2014
    The Male Components in this lot are made of material with lower strength than manufacturing specifications.
  • Z-1494-2011 unclassified · terminated · 29 Jan 2010
    Possible breakage. Structural weakness has been detected on the Male Driver 3.2mm and 4.0mm sizes. In certain cases, this weakness could lead to a premature failure of the instrument if it is submitted to large torsional loads higher than the normal forces required to introduce the male component.

Recalls matched to the 36 devices listed on this page; other pages of the family can carry others.

Variants

36 devices · page 1 of 1

Variants of FASSIER-DUVAL TELESCOPIC IM SYSTEM, Basic UDI-DI 7540194FD-PEGLE
UDI-DISize and differences
FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-PEG-20-016 FD-PEG-20-016 / FD-PEG-20-01607540194017505
Length 16 mm; Outer Diameter 2.0 mm
On the market
FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-PEG-20-020 FD-PEG-20-020 / FD-PEG-20-02007540194017512
Length 20 mm; Outer Diameter 2.0 mm
On the market
FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-PEG-20-024 FD-PEG-20-024 / FD-PEG-20-02407540194017529
Length 24 mm; Outer Diameter 2.0 mm
On the market
FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-PEG-20-028 FD-PEG-20-028 / FD-PEG-20-02807540194017536
Length 28 mm; Outer Diameter 2.0 mm
On the market
FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-PEG-20-032 FD-PEG-20-032 / FD-PEG-20-03207540194017543
Length 32 mm; Outer Diameter 2.0 mm
On the market
FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-PEG-20-036 FD-PEG-20-036 / FD-PEG-20-03607540194017550
Outer Diameter 2.0 mm; Length 36 mm
On the market
FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-PEG-20-040 FD-PEG-20-040 / FD-PEG-20-04007540194017567
Length 40 mm; Outer Diameter 2.0 mm
On the market
FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-PEG-20-044 FD-PEG-20-044 / FD-PEG-20-04407540194017574
Outer Diameter 2.0 mm; Length 44 mm
On the market
FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-PEG-20-048 FD-PEG-20-048 / FD-PEG-20-04807540194017581
Length 48 mm; Outer Diameter 2.0 mm
On the market
FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-PEG-20-052 FD-PEG-20-052 / FD-PEG-20-05207540194017598
Length 52 mm; Outer Diameter 2.0 mm
On the market
FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-PEG-20-056 FD-PEG-20-056 / FD-PEG-20-05607540194017604
Outer Diameter 2.0 mm; Length 56 mm
On the market
FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-PEG-20-060 FD-PEG-20-060 / FD-PEG-20-06007540194017611
Length 60 mm; Outer Diameter 2.0 mm
On the market
FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-PEG-24-016 FD-PEG-24-016 / FD-PEG-24-01607540194017628
Outer Diameter 2.4 mm; Length 16 mm
On the market
FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-PEG-24-020 FD-PEG-24-020 / FD-PEG-24-02007540194017635
Length 20 mm; Outer Diameter 2.4 mm
On the market
FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-PEG-24-024 FD-PEG-24-024 / FD-PEG-24-02407540194017642
Length 24 mm; Outer Diameter 2.4 mm
On the market
FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-PEG-24-028 FD-PEG-24-028 / FD-PEG-24-02807540194017659
Outer Diameter 2.4 mm; Length 28 mm
On the market
FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-PEG-24-032 FD-PEG-24-032 / FD-PEG-24-03207540194017932
Outer Diameter 2.4 mm; Length 32 mm
On the market
FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-PEG-24-036 FD-PEG-24-036 / FD-PEG-24-03607540194017826
Length 36 mm; Outer Diameter 2.4 mm
On the market
FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-PEG-24-040 FD-PEG-24-040 / FD-PEG-24-04007540194017833
Length 40 mm; Outer Diameter 2.4 mm
On the market
FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-PEG-24-044 FD-PEG-24-044 / FD-PEG-24-04407540194017840
Length 44 mm; Outer Diameter 2.4 mm
On the market
FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-PEG-24-048 FD-PEG-24-048 / FD-PEG-24-04807540194017857
Length 48 mm; Outer Diameter 2.4 mm
On the market
FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-PEG-24-052 FD-PEG-24-052 / FD-PEG-24-05207540194017864
Length 52 mm; Outer Diameter 2.4 mm
On the market
FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-PEG-24-056 FD-PEG-24-056 / FD-PEG-24-05607540194017871
Outer Diameter 2.4 mm; Length 56 mm
On the market
FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-PEG-24-060 FD-PEG-24-060 / FD-PEG-24-06007540194017888
Outer Diameter 2.4 mm; Length 60 mm
On the market
FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-PEG-28-016 FD-PEG-28-016 / FD-PEG-28-01607540194017895
Length 16 mm; Outer Diameter 2.8 mm
On the market
FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-PEG-28-020 FD-PEG-28-020 / FD-PEG-28-02007540194017901
Outer Diameter 2.8 mm; Length 20 mm
On the market
FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-PEG-28-024 FD-PEG-28-024 / FD-PEG-28-02407540194017918
Outer Diameter 2.8 mm; Length 24 mm
On the market
FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-PEG-28-028 FD-PEG-28-028 / FD-PEG-28-02807540194017925
Outer Diameter 2.8 mm; Length 28 mm
On the market
FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-PEG-28-032 FD-PEG-28-032 / FD-PEG-28-03207540194017666
Length 32 mm; Outer Diameter 2.8 mm
On the market
FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-PEG-28-036 FD-PEG-28-036 / FD-PEG-28-03607540194017673
Outer Diameter 2.8 mm; Length 36 mm
On the market
FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-PEG-28-040 FD-PEG-28-040 / FD-PEG-28-04007540194017680
Outer Diameter 2.8 mm; Length 40 mm
On the market
FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-PEG-28-044 FD-PEG-28-044 / FD-PEG-28-04407540194017697
Length 44 mm; Outer Diameter 2.8 mm
On the market
FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-PEG-28-048 FD-PEG-28-048 / FD-PEG-28-04807540194017703
Outer Diameter 2.8 mm; Length 48 mm
On the market
FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-PEG-28-052 FD-PEG-28-052 / FD-PEG-28-05207540194017710
Outer Diameter 2.8 mm; Length 52 mm
On the market
FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-PEG-28-056 FD-PEG-28-056 / FD-PEG-28-05607540194017727
Outer Diameter 2.8 mm; Length 56 mm
On the market
FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-PEG-28-060 FD-PEG-28-060 / FD-PEG-28-06007540194017734
Length 60 mm; Outer Diameter 2.8 mm
On the market