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Alliance 110040339

by Zimmer, Inc.

Alliance 110040339 is a Class II device made by Zimmer, Inc., cleared under FDA 510(k) K241043 on 15 May 2024 (1 earlier submission) and listed in FDA GUDID since 6 Aug 2025 (UDI-DI 00889024681996), active as of 22 Oct 2026. 5 FDA recalls are 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

5 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00889024681996 UDI-DI Date6 Aug 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK241043 Date15 May 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K241043 decided 15 May 2024 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00889024681996 listed 6 Aug 2025 Listed

Recalls

5 recalls · 5 ongoing · FDA

  • 5 recalls, same reason

    • Ongoing Z-2531-2026 FDA Class II initiated 20 May 2026
    • Ongoing Z-2528-2026 FDA Class II initiated 20 May 2026
    • Ongoing Z-2530-2026 FDA Class II initiated 20 May 2026
    • Ongoing Z-2529-2026 FDA Class II initiated 20 May 2026
    • Ongoing Z-2527-2026 FDA Class II initiated 20 May 2026

    Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

Timeline

8 dated events

  1. Cleared FDA 510(k) K233148
  2. Cleared FDA 510(k) K241043
  3. Listed FDA GUDID 00889024681996
  4. Recall initiated FDA recalls Z-2531-2026
  5. Recall initiated FDA recalls Z-2528-2026
  6. Recall initiated FDA recalls Z-2530-2026
  7. Recall initiated FDA recalls Z-2529-2026
  8. Recall initiated FDA recalls Z-2527-2026

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Alliance
Generic name
Orthopaedic inorganic implant inserter/extractor, reusable
Model / reference
110040339
Primary DI / UDI-DI
00889024681996
510(k) Number
FDA product code
KWT, PHX, KWS
GMDN term
Orthopaedic inorganic implant inserter/extractor, reusable
Device class
Class II
Regulation number
888.3650, 888.3660
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic inorganic implant inserter/extractor, reusable

Cleared under the same submission (K233148)

and 8 more cleared under K233148

Cleared under the same submission (K241043)

and 8 more cleared under K241043

Similar devices in this category

Other devices filed under Orthopaedic inorganic implant inserter/extractor, reusable.

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)