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Equinoxe® 322-42-03

by Exactech, Inc.

Equinoxe® 322-42-03 is a Class II device made by Exactech, Inc., cleared under FDA 510(k) K223833 on 14 Sep 2023 and listed in FDA GUDID since 28 Nov 2023 (UDI-DI 10885862593924), 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

510(k) K223833

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10885862593924 UDI-DI Date28 Nov 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK223833 Date14 Sep 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K223833 decided 14 Sep 2023 Active
  • FDA GUDID UDI-DI 10885862593924 listed 28 Nov 2023 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2562-2025 FDA Class II initiated 15 Aug 2025

    Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.

Timeline

3 dated events

  1. Cleared FDA 510(k) K223833
  2. Listed FDA GUDID 10885862593924
  3. Recall initiated FDA recalls Z-2562-2025

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Equinoxe®
Generic name
Polyethylene reverse shoulder prosthesis cup
Model / Ref / Catalog
322-42-03
Primary DI / UDI-DI
10885862593924
510(k) Number
FDA product code
KWS, KWT, PHX
GMDN term
Polyethylene reverse shoulder prosthesis cup
Device class
Class II
Regulation number
888.3660, 888.3650
GUDID distribution status
In Commercial Distribution

Related devices

Category: Polyethylene reverse shoulder prosthesis cup

Cleared under the same submission (K223833)

and 8 more cleared under K223833

Similar devices in this category

Other devices filed under Polyethylene reverse shoulder prosthesis cup.

Other devices from Exactech, Inc.

See all devices from Exactech, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Serial number
  • Expiration date
Other properties (9, all answered No)