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Global Unite 1407-20-102

by Depuy (Ireland)

Ref 1407-20-102Model GLOBAL UNITE Reverse Fracture Epiphysis

Global Unite 1407-20-102 (140720102) is a device classified as Class III in the EU and Class II in the US made by Depuy (Ireland), registered in EUDAMED on 23 Dec 2025 (Basic UDI-DI 0603295a003098P), cleared under FDA 510(k) K170748 on 11 Jan 2018 and listed in FDA GUDID since 15 Mar 2018 (UDI-DI 10603295446675), active as of 7 Nov 2026. 8 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

8 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K170748

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0603295a003098P Basic UDI-DI 10603295446675UDI-DIDate23 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10603295446675 UDI-DI Date15 Mar 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK170748 Date11 Jan 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0603295a003098P registered 23 Dec 2025 Active
  • FDA 510(k) K170748 decided 11 Jan 2018 Active
  • FDA GUDID UDI-DI 10603295446675 listed 15 Mar 2018 Listed

Recalls

8 recalls · FDA

  • 8 recalls, same reason

    • Terminated Z-0483-2022 FDA Class II initiated 7 Dec 2021
    • Terminated Z-0486-2022 FDA Class II initiated 7 Dec 2021
    • Terminated Z-0489-2022 FDA Class II initiated 7 Dec 2021
    • Terminated Z-0488-2022 FDA Class II initiated 7 Dec 2021
    • Terminated Z-0485-2022 FDA Class II initiated 7 Dec 2021
    • Terminated Z-0490-2022 FDA Class II initiated 7 Dec 2021
    • Terminated Z-0484-2022 FDA Class II initiated 7 Dec 2021
    • Terminated Z-0487-2022 FDA Class II initiated 7 Dec 2021

    Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage

Timeline

11 dated events

  1. Listed FDA GUDID 10603295446675
  2. Recall initiated FDA recalls Z-0483-2022
  3. Recall initiated FDA recalls Z-0486-2022
  4. Recall initiated FDA recalls Z-0489-2022
  5. Recall initiated FDA recalls Z-0488-2022
  6. Recall initiated FDA recalls Z-0485-2022
  7. Recall initiated FDA recalls Z-0490-2022
  8. Recall initiated FDA recalls Z-0484-2022
  9. Recall initiated FDA recalls Z-0487-2022
  10. Registered EUDAMED 0603295a003098P

1 earlier event are in the sections above.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Global Unite
Generic name
Reverse shoulder prosthesis body
Device name
GLOBAL UNITE Reverse Fracture Epiphysis
Model / Ref / Catalog
1407-20-102, GLOBAL UNITE Reverse Fracture Epiphysis, 140720102
Primary DI / UDI-DI
10603295446675
Basic UDI-DI
0603295a003098P
510(k) Number
FDA product code
PHX, HSD, KWS
EMDN code
P090104010201 Epiphysary humeral components for reverse prostheses - inserts
GMDN term
Reverse shoulder prosthesis body
Device class
Class III EUDAMED
Class II GUDID
Regulation number
888.3660, 888.3690
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II

Device class is stated on each registry's own scale: Class III in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Reverse shoulder prosthesis body

Cleared under the same submission (K170748)

and 8 more cleared under K170748

Similar devices in this category

Other devices filed under EPIPHYSARY HUMERAL COMPONENTS FOR REVERSE PROSTHESES - INSERTS.

Other devices from Depuy (Ireland)

See all devices from Depuy (Ireland) →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)