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Unity Total Knee System 123.350.00

by Corin Ltd

Ref 123.350.00Model Unity Total Knee instrument set

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

2 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 24 Oct 2026. What this means

Overview

The Unity Total Knee System is a hand-held manual surgical instrument designed for the precise and effective insertion and extraction of non-tissue-based orthopaedic implants, such as bone nails, spiral blades, or fixation plates. This modular device features a region that attaches to part of the implant, allowing for versatile use in various knee replacement procedures.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05055343886823 Basic UDI-DI 05055343886823UDI-DIDate15 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055343886823 UDI-DI Date17 Aug 2016ListedStatusListed 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 · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0213-2024 FDA Class II initiated 13 Oct 2023
    • Ongoing Z-0214-2024 FDA Class II initiated 13 Oct 2023

    Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa.

    • Terminated Z-0273-2023 FDA Class II initiated 31 Oct 2022

    The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Pin Driver (Hall-Zimmer Drive) EUDAMED
Unity Total Knee System GUDID
Generic Name
Orthopaedic inorganic implant inserter/extractor, reusable
Model / Ref / Catalog
123.350.00, Unity Total Knee instrument set
Primary DI / UDI-DI
05055343886823
Basic UDI-DI
B-05055343886823
510(k) Number
FDA Product Code
JWH
EMDN Code
L0999 Orthopaedic and traumatological surgery instruments, reusable - other
GMDN Term
Orthopaedic inorganic implant inserter/extractor, reusable
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
888.3560
EU market of registration
France
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 IIa
GUDID
Class II

Related devices

Category: Orthopaedic inorganic implant inserter/extractor, reusable

Cleared under the same submission (K113060)

Show all (12)

Other devices from Corin Ltd

See all devices from Corin Ltd →

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