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Equinoxe 314-04-25

by Exactech, Inc.

Equinoxe 314-04-25 is a Class II device made by Exactech, Inc., cleared under FDA 510(k) K111379 on 8 Jun 2011 and listed in FDA GUDID since 30 Oct 2015 (UDI-DI 10885862199584), active as of 23 Oct 2026. 2 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

2 ongoing

This device is named in the recall

Documents

510(k) K111379

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 Number10885862199584 UDI-DI Date30 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK111379 Date8 Jun 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K111379 decided 8 Jun 2011 Active
  • FDA GUDID UDI-DI 10885862199584 listed 30 Oct 2015 Listed

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1408-2024 FDA Class II initiated 6 Mar 2024
    • Ongoing Z-1409-2024 FDA Class II initiated 6 Mar 2024

    The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

Timeline

4 dated events

  1. Cleared FDA 510(k) K111379
  2. Listed FDA GUDID 10885862199584
  3. Recall initiated FDA recalls Z-1408-2024
  4. Recall initiated FDA recalls Z-1409-2024

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  • Withdrawn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
Shoulder glenoid fossa prosthesis, prefabricated
Model / Ref / Catalog
314-04-25
Primary DI / UDI-DI
10885862199584
510(k) Number
FDA product code
KWS
GMDN term
Shoulder glenoid fossa prosthesis, prefabricated
Device class
Class II
Regulation number
888.3660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Shoulder glenoid fossa prosthesis, prefabricated

Cleared under the same submission (K111379)

and 8 more cleared under K111379

Similar devices in this category

Other devices filed under Shoulder glenoid fossa prosthesis, prefabricated.

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)