Skip to content

Na 802602801

by Zimmer, Inc. 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

5 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00889024499881 UDI-DI Date7 Jun 2019ListedStatusListed GUDID: in commercial distribution

Recalls

5 recalls · 5 ongoing · FDA

  • 5 recalls, same reason

    • Ongoing Z-1645-2025 FDA Class II initiated 24 Mar 2025
    • Ongoing Z-1648-2025 FDA Class II initiated 24 Mar 2025
    • Ongoing Z-1649-2025 FDA Class II initiated 24 Mar 2025
    • Ongoing Z-1647-2025 FDA Class II initiated 24 Mar 2025
    • Ongoing Z-1646-2025 FDA Class II initiated 24 Mar 2025

    The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Ceramic femoral head prosthesis
Model / Ref / Catalog
802602801
Primary DI / UDI-DI
00889024499881
510(k) Number
FDA Product Code
KWY, KWZ, LZO
GMDN Term
Ceramic femoral head prosthesis
Device Class
Class II
Regulation Number
888.3390, 888.3310, 888.3353
GUDID distribution status
In Commercial Distribution

Related devices

Category: Ceramic femoral head prosthesis

Cleared under the same submission (K181171)

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