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Global Unite 1100-40-610

by Depuy (Ireland)

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

8 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10603295004509 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Recalls

8 recalls · FDA

  • 8 recalls, same reason

    • Terminated Z-0483-2022 FDA Class II initiated 7 Dec 2021 on shared 510(k) K101996
    • Terminated Z-0486-2022 FDA Class II initiated 7 Dec 2021 on shared 510(k) K101996
    • Terminated Z-0489-2022 FDA Class II initiated 7 Dec 2021 on shared 510(k) K101996
    • Terminated Z-0488-2022 FDA Class II initiated 7 Dec 2021 on shared 510(k) K101996
    • Terminated Z-0485-2022 FDA Class II initiated 7 Dec 2021 on shared 510(k) K101996
    • Terminated Z-0490-2022 FDA Class II initiated 7 Dec 2021 on shared 510(k) K101996
    • Terminated Z-0484-2022 FDA Class II initiated 7 Dec 2021 on shared 510(k) K101996
    • Terminated Z-0487-2022 FDA Class II initiated 7 Dec 2021 on shared 510(k) K101996

    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

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Global Unite
Generic Name
Stem-fixed metallic humeral head prosthesis
Model / Ref / Catalog
1100-40-610, 110040610
Primary DI / UDI-DI
10603295004509
510(k) Number
FDA Product Code
HSD, KWS, MBF
GMDN Term
Stem-fixed metallic humeral head prosthesis
Device Class
Class II
Regulation Number
888.3690, 888.3660, 888.3670
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Related devices

Category: Stem-fixed metallic humeral head prosthesis

Cleared under the same submission (K101996)

Show all (12)

Cleared under the same submission (K170748)

Show all (12)

Other devices from Depuy (Ireland)

See all devices from Depuy (Ireland) →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No