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Na 802303600

by Zimmer, Inc. United States GUDID

Product code LZO

Regulatory status

as of 25 Oct 2026

Recall ongoing. 5 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00889024499263 UDI-DIDate20 Aug 2020ListedStatusIn distribution

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Listed
  • Not covered

United States — GUDID listing Listed

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.

Specification

GUDID · synced 22 Oct 2026

Trade Name
Na
Generic Name
Femoral head prosthesis trial
Model / Ref / Catalog
802303600
Primary DI / UDI-DI
00889024499263
510(k) Number
FDA Product Code
LZO, OQG, KWZ, KWY, LPH
GMDN Term
Femoral head prosthesis trial
Device Class
Class II
Regulation Number
888.3353, 888.3358, 888.3310, 888.3390
Commercial Distribution
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Femoral head prosthesis trial

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Cleared under the same submission (K183457)

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Other devices from Zimmer, Inc.

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Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Lot / Batch Number
Other properties (12)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (1)

  • FDA UDI d931c8ea-c07a-4adf-994e-7d6fb416885a 36 fields · synced 22 Oct 2026