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2.5 TriLock Dist.Rad.FramePl Volar Right

by Medartis AG EUDAMEDGUDID

Active European Union Open recall (shared submission)

Ref A-4750.06

Regulatory status

as of 28 Oct 2026

Recall ongoing. 1 ongoing FDA recall on shared 510(k) K051567: the recalled product is another device cleared under the same submission. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number76300378020P6 Basic UDI-DIDate25 Mar 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07630037894292 UDI-DIDate24 Feb 2023ListedStatusListed 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  • Withdrawn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

1 recall · 1 ongoing · FDA

    • Ongoing Z-1549-2026 FDA Class II initiated 9 Jan 2026 on shared 510(k) K051567

    Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.

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

Specification

EUDAMED · GUDID

Trade Name
2.5 TriLock Dist.Rad.FramePl Volar Right EUDAMED
Aptus GUDID
Generic Name
Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Device Name
Bone plates (sterile, non-sterile)
Model / Ref / Catalog
A-4750.06
Primary DI / UDI-DI
07630037894292
Basic UDI-DI
76300378020P6
510(k) Number
FDA Product Code
HRS
EMDN Code
P09120599 Bone fixation plates - other
GMDN Term
Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3030
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Manufacturer details

EUDAMED SRN
CH-MF-000022291
Authorised representative
Medartis GmbH DE-AR-000005810

Related devices

Category: Orthopaedic fixation plate, non-bioabsorbable

Other devices from Medartis AG

See all devices from Medartis AG →

Properties

  • Single Use
  • Implantable YesEUDAMEDNoGUDID
  • Sutures
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • 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