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Equinoxe 301-01-11

by Exactech, Inc.

Equinoxe 301-01-11 is a Class II device made by Exactech, Inc., cleared under FDA 510(k) K042021 on 26 Oct 2004 and listed in FDA GUDID since 18 Aug 2022 (UDI-DI 10885862079565), active as of 23 Oct 2026. 7 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

8 ongoing

This device is named in the recall

Documents

510(k) K042021

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 Number10885862079565 UDI-DI Date18 Aug 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK042021 Date26 Oct 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K042021 decided 26 Oct 2004 Active
  • FDA GUDID UDI-DI 10885862079565 listed 18 Aug 2022 Listed

Recalls

10 recalls · 8 ongoing · FDA

  • 3 recalls, same reason

    • 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
    • Ongoing Z-0537-2026 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.

  • 4 recalls, same reason

    • Ongoing Z-1404-2024 FDA Class II initiated 6 Mar 2024
    • Ongoing Z-1402-2024 FDA Class II initiated 6 Mar 2024
    • Ongoing Z-1405-2024 FDA Class II initiated 6 Mar 2024
    • Ongoing Z-1403-2024 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-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.

    • 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.

    • 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

12 dated events

  1. Recall initiated FDA recalls Z-1459-2015
  2. Recall initiated FDA recalls Z-0884-2021
  3. Listed FDA GUDID 10885862079565
  4. Recall initiated FDA recalls Z-1404-2024
  5. Recall initiated FDA recalls Z-1402-2024
  6. Recall initiated FDA recalls Z-1405-2024
  7. Recall initiated FDA recalls Z-1403-2024
  8. Recall initiated FDA recalls Z-0536-2026
  9. Recall initiated FDA recalls Z-0535-2026
  10. Recall initiated FDA recalls Z-0537-2026

2 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 broach
Model / Ref / Catalog
301-01-11
Primary DI / UDI-DI
10885862079565
510(k) Number
FDA product code
HSD, KWS
GMDN term
Orthopaedic broach
Device class
Class II
Regulation number
888.3690, 888.3660
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 11 Millimeter

Related devices

Category: Orthopaedic broach

Cleared under the same submission (K042021)

and 8 more cleared under K042021

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)