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Equinoxe 301-09-00

by Exactech, Inc.

Equinoxe 301-09-00 is a Class II device made by Exactech, Inc., cleared under FDA 510(k) K063569 on 23 Feb 2007 (2 earlier submissions) and listed in FDA GUDID since 28 Jul 2022 (UDI-DI 10885862560865), active as of 23 Oct 2026. 11 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

17 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10885862560865 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· +2 more in the status table
  • FDA GUDID UDI-DI 10885862560865 listed 28 Jul 2022 Listed

Recalls

23 recalls · 17 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-0537-2026 FDA Class II initiated 5 Sep 2025 on shared 510(k) K042021
    • Ongoing Z-0536-2026 FDA Class II initiated 5 Sep 2025 on shared 510(k) K042021
    • Ongoing Z-0535-2026 FDA Class II initiated 5 Sep 2025 on shared 510(k) K042021

    Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.

    • 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.

  • 10 recalls, same reason

    • Ongoing Z-1419-2024 FDA Class II initiated 6 Mar 2024 on shared 510(k) K063569
    • Ongoing Z-1405-2024 FDA Class II initiated 6 Mar 2024
    • 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-1403-2024 FDA Class II initiated 6 Mar 2024
    • Ongoing Z-1418-2024 FDA Class II initiated 6 Mar 2024 on shared 510(k) K063569
    • Ongoing Z-1404-2024 FDA Class II initiated 6 Mar 2024
    • Ongoing Z-1423-2024 FDA Class II initiated 6 Mar 2024 on shared 510(k) K063569
    • Ongoing Z-1402-2024 FDA Class II initiated 6 Mar 2024
    • Ongoing Z-1425-2024 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-0884-2021 FDA Class II initiated 9 Nov 2020

    Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.

    • 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-1459-2015 FDA Class II initiated 13 Feb 2015

    Incorrectly packaged. Outer and inner labeling may incorrectly identify the size of the enclosed device.

  • 2 recalls, same reason

    • Terminated Z-2117-2012 FDA Class II initiated 15 Jun 2012
    • Terminated Z-2115-2012 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

27 dated events

  1. Recall initiated FDA recalls Z-1403-2024
  2. Recall initiated FDA recalls Z-1418-2024
  3. Recall initiated FDA recalls Z-1404-2024
  4. Recall initiated FDA recalls Z-1423-2024
  5. Recall initiated FDA recalls Z-1402-2024
  6. Recall initiated FDA recalls Z-1425-2024
  7. Recall initiated FDA recalls Z-2561-2025
  8. Recall initiated FDA recalls Z-0537-2026
  9. Recall initiated FDA recalls Z-0536-2026
  10. Recall initiated FDA recalls Z-0535-2026

17 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
Bone-resection orthopaedic reamer, reusable
Model / Ref / Catalog
301-09-00
Primary DI / UDI-DI
10885862560865
510(k) Number
FDA product code
KWS, KWT, HSD
GMDN term
Bone-resection orthopaedic reamer, reusable
Device class
Class II
Regulation number
888.3660, 888.3650, 888.3690
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Bone-resection orthopaedic reamer, reusable

Cleared under the same submission (K042021)

and 8 more cleared under K042021

Cleared under the same submission (K061454)

and 8 more cleared under K061454

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)