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Na 6815-19-185

by Zimmer, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

5 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 Number00889024262324 UDI-DI Date17 Sep 2015ListedStatusListed GUDID: in commercial distribution

Recalls

5 recalls · FDA

    • Terminated Z-2092-2023 FDA Class II initiated 19 May 2023

    Device outer packaging was incorrectly labeled.

    • Terminated Z-0321-2020 FDA Class II initiated 10 Oct 2019

    Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

    • Terminated Z-1250-2014 FDA Class II initiated 25 Feb 2014

    A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.

    • Terminated Z-0996-2009 FDA Unclassified (pre-2012) initiated 29 Jan 2009

    The package contains 11 mm screws instead of the specified 6 mm screws.

    • Terminated Z-0539-05 FDA Unclassified (pre-2012) initiated 17 Dec 2004

    Risk of adapter disassociation from mating components when assembled improperly or when subjected to high-stress femoral applications.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Knee femur stem prosthesis
Model / Ref / Catalog
6815-19-185
Primary DI / UDI-DI
00889024262324
510(k) Number
FDA Product Code
LZO, KRO, JWH
GMDN Term
Knee femur stem prosthesis
Device Class
Class II
Regulation Number
888.3353, 888.3510, 888.3560
GUDID distribution status
In Commercial Distribution

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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