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Instrument 6541-1-609Y

by Howmedica Osteonics Corp.

Ref 6541-1-609YModel 08858250000796SV

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

3 ongoing

This device is named in the recall

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 Number08858250000796SV Basic UDI-DI 07613327403787UDI-DIDate19 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327403787 UDI-DI Date4 May 2020ListedStatusListed 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

3 recalls · 3 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1260-2024 FDA Class II initiated 6 Feb 2024
    • Ongoing Z-1259-2024 FDA Class II initiated 6 Feb 2024

    Potential packaging breaches of inner blister and outer sterile blister.

    • Ongoing Z-1653-2023 FDA Class II initiated 13 Apr 2023

    Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM, may contain Catalog Number: 5532-G-413-E, TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM, and vice versa

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  • Withdrawn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
Triathlon EUDAMED
Instrument GUDID
Generic Name
Surgical instrument handle, non-torque-limiting
Device Name
TF-018 Class I (r) - Positioning
Model / Ref / Catalog
6541-1-609Y, 08858250000796SV
Primary DI / UDI-DI
07613327403787
Basic UDI-DI
08858250000796SV
Direct Marketing DI
07613327403787
510(k) Number
FDA Product Code
MBH, JWH
EMDN Code
L091106 Instruments for the preparation of tissue implants in orthopaedic and traumatological surgery, reusable
GMDN Term
Surgical instrument handle, non-torque-limiting
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
888.3565, 888.3560
Market of Registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Category: Surgical instrument handle, non-torque-limiting

Cleared under the same submission (K173849)

Show all (12)

Other devices from Howmedica Osteonics Corp.

See all devices from Howmedica Osteonics Corp. →

Properties

  • Reusable
  • CMR Substance
  • Prescription Use
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: 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