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Equinoxe 301-10-00

by Exactech, Inc.

Equinoxe 301-10-00 is a Class II device made by Exactech, Inc., cleared under FDA 510(k) K121067 on 6 Dec 2012 (2 earlier submissions) and listed in FDA GUDID since 28 Jul 2022 (UDI-DI 10885862079787), active as of 23 Oct 2026. 12 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

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10885862079787 UDI-DI Date28 Jul 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK121067 Date6 Dec 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K121067 decided 6 Dec 2012 Active· +2 more in the status table
  • FDA GUDID UDI-DI 10885862079787 listed 28 Jul 2022 Listed

Recalls

12 recalls · 8 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-0536-2026 FDA Class II initiated 5 Sep 2025
    • Ongoing Z-0535-2026 FDA Class II initiated 5 Sep 2025
    • Ongoing Z-0537-2026 FDA Class II initiated 5 Sep 2025

    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.

  • 3 recalls, same reason

    • Terminated Z-2115-2012 FDA Class II initiated 15 Jun 2012
    • Terminated Z-2119-2012 FDA Class II initiated 15 Jun 2012
    • Terminated Z-2116-2012 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

Timeline

16 dated events

  1. Recall initiated FDA recalls Z-1459-2015
  2. Recall initiated FDA recalls Z-0884-2021
  3. Listed FDA GUDID 10885862079787
  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

6 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
Surgical instrument handle, non-torque-limiting
Model / Ref / Catalog
301-10-00
Primary DI / UDI-DI
10885862079787
510(k) Number
FDA product code
PHX, KWT, HSD, KWS
GMDN term
Surgical instrument handle, non-torque-limiting
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: Surgical instrument handle, non-torque-limiting

Cleared under the same submission (K042021)

and 8 more cleared under K042021

Cleared under the same submission (K102951)

and 8 more cleared under K102951

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)