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Equinoxe 320-36-00

by Exactech, Inc.

Equinoxe 320-36-00 is a Class II device made by Exactech, Inc., cleared under FDA 510(k) K093275 on 27 May 2010 and listed in FDA GUDID since 30 Oct 2015 (UDI-DI 10885862086617), 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

3 ongoing

This device is named in the recall

Documents

510(k) K093275

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 Number10885862086617 UDI-DI Date30 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK093275 Date27 May 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K093275 decided 27 May 2010 Active
  • FDA GUDID UDI-DI 10885862086617 listed 30 Oct 2015 Listed

Recalls

3 recalls · 3 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1416-2024 FDA Class II initiated 6 Mar 2024 on shared 510(k) K093275
    • Ongoing Z-1417-2024 FDA Class II initiated 6 Mar 2024 on shared 510(k) K093275

    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).

    • Ongoing Z-0579-2024 FDA Class II initiated 21 Nov 2023

    Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

5 dated events

  1. Cleared FDA 510(k) K093275
  2. Listed FDA GUDID 10885862086617
  3. Recall initiated FDA recalls Z-0579-2024
  4. Recall initiated FDA recalls Z-1416-2024
  5. Recall initiated FDA recalls Z-1417-2024

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  • Withdrawn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
Polyethylene reverse shoulder prosthesis cup
Model / Ref / Catalog
320-36-00
Primary DI / UDI-DI
10885862086617
510(k) Number
FDA product code
KWT, KWS
GMDN term
Polyethylene reverse shoulder prosthesis cup
Device class
Class II
Regulation number
888.3650, 888.3660
GUDID distribution status
In Commercial Distribution
Size
Lumen/Inner Diameter — 36 Millimeter

Related devices

Category: Polyethylene reverse shoulder prosthesis cup

Cleared under the same submission (K093275)

and 2 more cleared under K093275

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)