Skip to content

Equinoxe 301-10-10

by Exactech, Inc.

Equinoxe 301-10-10 is a Class II device made by Exactech, Inc., cleared under FDA 510(k) K063569 on 23 Feb 2007 and listed in FDA GUDID since 28 Jul 2022 (UDI-DI 10885862079800), active as of 23 Oct 2026. 4 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

9 ongoing

This device is named in the recall

Documents

510(k) K063569

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 Number10885862079800 UDI-DI Date28 Jul 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK063569 Date23 Feb 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K063569 decided 23 Feb 2007 Active
  • FDA GUDID UDI-DI 10885862079800 listed 28 Jul 2022 Listed

Recalls

13 recalls · 9 ongoing · FDA

    • Ongoing Z-2561-2025 FDA Class II initiated 15 Aug 2025 on shared 510(k) K063569

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

  • 6 recalls, same reason

    • Ongoing Z-1425-2024 FDA Class II initiated 6 Mar 2024 on shared 510(k) K063569
    • Ongoing Z-1423-2024 FDA Class II initiated 6 Mar 2024 on shared 510(k) K063569
    • Ongoing Z-1419-2024 FDA Class II initiated 6 Mar 2024 on shared 510(k) K063569
    • Ongoing Z-1422-2024 FDA Class II initiated 6 Mar 2024 on shared 510(k) K063569
    • Ongoing Z-1424-2024 FDA Class II initiated 6 Mar 2024 on shared 510(k) K063569
    • Ongoing Z-1418-2024 FDA Class II initiated 6 Mar 2024 on shared 510(k) K063569

    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.

    • Ongoing Z-0012-2019 FDA Class II initiated 21 Aug 2018

    The Equinoxe Reverse Drill Bit Kits may contain two 2mm diameter drill bits instead of one 2mm diameter drill bit and one 3.2mm diameter drill bit as intended.

  • 2 recalls, same reason

    • Terminated Z-3019-2020 FDA Class II initiated 24 Aug 2020 on shared 510(k) K063569
    • Terminated Z-3020-2020 FDA Class II initiated 24 Aug 2020 on shared 510(k) K063569

    Exactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it may contain a incorrect length screw.

    • Terminated Z-0900-2017 FDA Class II initiated 25 Oct 2016

    Disengaged screw head could potentially not be retained in the Torque Defining Screwdriver.

    • Terminated Z-2117-2012 FDA Class II initiated 15 Jun 2012

    Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion devices due to the firm determining that the device labeling identifies the affected parts as having a ten year shelf life; however, the packaging configuration that was used it qualified to a five year

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

Timeline

15 dated events

  1. Recall initiated FDA recalls Z-3020-2020
  2. Listed FDA GUDID 10885862079800
  3. Recall initiated FDA recalls Z-0579-2024
  4. Recall initiated FDA recalls Z-1425-2024
  5. Recall initiated FDA recalls Z-1423-2024
  6. Recall initiated FDA recalls Z-1419-2024
  7. Recall initiated FDA recalls Z-1422-2024
  8. Recall initiated FDA recalls Z-1424-2024
  9. Recall initiated FDA recalls Z-1418-2024
  10. Recall initiated FDA recalls Z-2561-2025

5 earlier events are in the sections above.

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
Orthopaedic instrument extractor
Model / Ref / Catalog
301-10-10
Primary DI / UDI-DI
10885862079800
510(k) Number
FDA product code
KWT
GMDN term
Orthopaedic instrument extractor
Device class
Class II
Regulation number
888.3650
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic instrument extractor

Cleared under the same submission (K063569)

and 8 more cleared under K063569

Other devices from Exactech, Inc.

See all devices from Exactech, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)