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Anatomical Shoulder™ Domelock® 01.04227.218

by Zimmer, Inc. 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 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 Number00889024275225 UDI-DI Date27 Jul 2017ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-2003-2016 FDA Class II initiated 17 May 2016

    In some cases it has been difficult or not possible to disassemble the adjusted Dome Centric from the AS Humeral Rasp after initial positioning of the AS Humeral Trial Head which resulted in the whole construct of the Dome Centric with the still assembled AS Humeral Rasp taken out of the humeral canal. This could cause a delay in surgery time or the surgeon could decide to close the wound without finishing the surgery, increasing the infection risk or second use of anesthesia necessary.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Anatomical Shoulder™ Domelock®
Generic Name
Total shoulder prosthesis
Model / Reference
01.04227.218
Primary DI / UDI-DI
00889024275225
510(k) Number
FDA Product Code
PHX, KWT, HSD, KWS
GMDN Term
Total shoulder prosthesis
Device Class
Class II
Regulation Number
888.3660, 888.3650, 888.3690
GUDID distribution status
In Commercial Distribution

Related devices

Category: Total shoulder prosthesis

Cleared under the same submission (K142403)

Show all (12)

Other devices from Zimmer, Inc.

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Properties

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

Other properties (7)

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