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Z1™ Hip System 611101000

by Zimmer, Inc.

Z1™ Hip System 611101000 is a Class II device made by Zimmer, Inc., cleared under FDA 510(k) K251906 on 18 Jul 2025 (1 earlier submission) and listed in FDA GUDID since 9 Sep 2024 (UDI-DI 00887868575846), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK251906 Date18 Jul 2025DecidedStatusActive
United StatesGUDID listing Number00887868575846 UDI-DI Date9 Sep 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K251906 decided 18 Jul 2025 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00887868575846 listed 9 Sep 2024 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1329-2025 FDA Class II initiated 12 Feb 2025

    There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the distal tip.

Timeline

4 dated events

  1. Cleared FDA 510(k) K233476
  2. Listed FDA GUDID 00887868575846
  3. Recall initiated FDA recalls Z-1329-2025
  4. Cleared FDA 510(k) K251906

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Z1™ Hip System
Generic name
Coated hip femur prosthesis, modular
Model / Ref / Catalog
611101000
Primary DI / UDI-DI
00887868575846
510(k) Number
FDA product code
MEH, KWZ, LWJ, LZO, KWY
GMDN term
Coated hip femur prosthesis, modular
Device class
Class II
Regulation number
888.3353, 888.3310, 888.3360, 888.3390
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Coated hip femur prosthesis, modular

Cleared under the same submission (K233476)

and 8 more cleared under K233476

Cleared under the same submission (K251906)

and 8 more cleared under K251906

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)