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Simple Locking Intramedullary (Slim) System Blt-48-028

by Orthopediatrics Canada ULC EUDAMEDGUDID

Active European Union Open recall (shared submission)

Ref BLT-48-028Model BULLET ASSEMBLY

Regulatory status

as of 29 Oct 2026

Recall ongoing. 1 ongoing FDA recall on shared 510(k) K041393: the recalled product is another device cleared under the same submission. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7540194SLM-BULL4H Basic UDI-DIDate26 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07540194011428 UDI-DIDate19 Mar 2021ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

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

    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

    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

    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

    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.

Specification

EUDAMED · GUDID

Trade Name
The Simple Locking Intra Medullary System EUDAMED
Simple Locking Intramedullary (Slim) System GUDID
Generic Name
Orthopaedic bone screw (non-sliding)
Model / Ref / Catalog
BLT-48-028, BULLET ASSEMBLY
Primary DI / UDI-DI
07540194011428
Basic UDI-DI
7540194SLM-BULL4H
510(k) Number
FDA Product Code
HSB
EMDN Code
P09120601 Cortical screws
GMDN Term
Orthopaedic bone screw (non-sliding)
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3020
Market of Registration
Sweden
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Length — 28 Millimeter
Outer Diameter — 4.8 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Orthopaedic bone screw (non-sliding)

Cleared under the same submission (K020885)

Show all (12)

Cleared under the same submission (K041393)

Show all (12)

Other devices from Orthopediatrics Canada ULC

See all devices from Orthopediatrics Canada ULC →

Properties

  • Single Use
  • Implantable
  • Sutures
  • Prescription Use
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • Reusable: 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