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Equinoxe Reverse Shoulder System

by Exactech, Inc.

510(k) K063569

Equinoxe Reverse Shoulder System is a Class II device made by Exactech, Inc., cleared under FDA 510(k) K063569 on 23 Feb 2007, active as of 22 Oct 2026. 9 FDA recalls are linked to it.

Active United States

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

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK063569 Date23 Feb 2007ClearedStatusActive

Official records

Recalls

13 recalls · 9 ongoing · FDA

    • Ongoing Z-2561-2025 FDA Class II initiated 15 Aug 2025

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

  • 6 recalls, same reason

    • Ongoing Z-1425-2024 FDA Class II initiated 6 Mar 2024
    • Ongoing Z-1423-2024 FDA Class II initiated 6 Mar 2024
    • Ongoing Z-1419-2024 FDA Class II initiated 6 Mar 2024
    • Ongoing Z-1422-2024 FDA Class II initiated 6 Mar 2024
    • Ongoing Z-1424-2024 FDA Class II initiated 6 Mar 2024
    • Ongoing Z-1418-2024 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).

    • Ongoing Z-0579-2024 FDA Class II initiated 21 Nov 2023 on shared 510(k) K063569

    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 on shared 510(k) K063569

    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
    • Terminated Z-3020-2020 FDA Class II initiated 24 Aug 2020

    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 on shared 510(k) K063569

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

    • Terminated Z-2117-2012 FDA Class II initiated 15 Jun 2012 on shared 510(k) K063569

    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

14 dated events

  1. Recall initiated FDA recalls Z-3019-2020
  2. Recall initiated FDA recalls Z-3020-2020
  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

4 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

510(k)

510(k) Number
FDA product code
PHX
Device class
Class II
Regulation
21 CFR Part 888.3660
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

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