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Anatomical Shoulder# 01.04227.485

by Zimmer, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

3 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 Number00889024286306 UDI-DI Date16 Oct 2015ListedStatusListed GUDID: in commercial distribution

Recalls

3 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0233-2013 FDA Class II initiated 4 Sep 2012
    • Terminated Z-0224-2013 FDA Class II initiated 4 Sep 2012

    Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info

    • Terminated Z-0227-2013 FDA Class II initiated 4 Sep 2012

    Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Anatomical Shoulder#
Generic Name
Total shoulder prosthesis
Model / Reference
01.04227.485
Primary DI / UDI-DI
00889024286306
510(k) Number
FDA Product Code
HSD, KWS
GMDN Term
Total shoulder prosthesis
Device Class
Class II
Regulation Number
888.3690, 888.3660
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 48 Millimeter

Related devices

Category: Total shoulder prosthesis

Cleared under the same submission (K062029)

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