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Fassier-Duval Telescopic Im System Fd-Peg-PGD128

by Orthopediatrics Canada ULC

Ref FD-PEG-PGD128Model PEG DRILL

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

1 ongoing

Recall on shared 510(k) K041393; other models may be affected

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7540194FD-PGDLE Basic UDI-DI 07540194017819UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07540194017819 UDI-DI Date10 Sep 2024ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

5 recalls · 1 ongoing · FDA

    • Ongoing Z-2941-2024 FDA Class II initiated 4 Jul 2024 on shared 510(k) K041393

    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.

    • Terminated Z-1546-2015 FDA Class II initiated 10 Apr 2015 on shared 510(k) K041393

    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.

    • Terminated Z-1472-2014 FDA Class II initiated 5 Mar 2014 on shared 510(k) K041393

    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.

    • Terminated Z-1448-2014 FDA Class II initiated 7 Feb 2014 on shared 510(k) K041393

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

    • Terminated Z-1494-2011 FDA Unclassified (pre-2012) initiated 29 Jan 2010 on shared 510(k) K041393

    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 on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
The Fassier-Duval Telescopic IM System EUDAMED
Fassier-Duval Telescopic Im System GUDID
Generic Name
Fluted surgical drill bit, reusable
Model / Ref / Catalog
FD-PEG-PGD128, PEG DRILL
Primary DI / UDI-DI
07540194017819
Basic UDI-DI
7540194FD-PGDLE
510(k) Number
FDA Product Code
HTW
EMDN Code
Z12130503 Orthopaedic surgical drills
GMDN Term
Fluted surgical drill bit, reusable
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
888.4540
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Length — 150 Millimeter
Outer Diameter — 2.75 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Related devices

Cleared under the same submission (K041393)

Show all (12)

Other devices from Orthopediatrics Canada ULC

See all devices from Orthopediatrics Canada ULC →

Properties

  • Reusable
  • Prescription Use
  • Lot / Batch Number

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No