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Na 5842-12-02

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 Number00889024193734 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Recalls

3 recalls · FDA

    • Terminated Z-1054-2018 FDA Class II initiated 29 Nov 2017

    The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

    • Terminated Z-0836-2016 FDA Class II initiated 11 Jan 2016

    LDPE bag containing the implant adheres to the highly polished implant surface.

    • Terminated Z-0076-2014 FDA Class II initiated 30 Aug 2013

    The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Uncoated unicondylar knee femur prosthesis
Model / Ref / Catalog
5842-12-02, 00-5842-012-02
Primary DI / UDI-DI
00889024193734
510(k) Number
FDA Product Code
HSX
GMDN Term
Uncoated unicondylar knee femur prosthesis
Device Class
Class II
Regulation Number
888.3520
GUDID distribution status
In Commercial Distribution

Related devices

Category: Uncoated unicondylar knee femur prosthesis

Cleared under the same submission (K033363)

Show all (12)

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

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