Equinoxe Central Screw Baseplate System

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

• • 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

  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
  • 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

  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

Trade Name

Equinoxe® EUDAMED

Equinoxe GUDID

Generic Name

Surgical depth gauge, reusable

Hand-held surgical retractor, reusable

Model / Ref / Catalog

321-19-09, 317-11-03, Equinoxe®

Primary DI / UDI-DI

10885862558480, 10885862557506

Basic UDI-DI

10885862100209P4, 10885862100092P7

510(k) Number

K233482 ↗ 510(k)

K063569 ↗ GUDID

FDA Product Code

PHX 510(k)

KWT GUDID

GAD GUDID

EMDN Code

L091199, L0915

GMDN Term

Surgical depth gauge, reusable

Hand-held surgical retractor, reusable

Device Class

Class I EUDAMEDGUDID

Class II 510(k)GUDID

Regulation

21 CFR Part 888.3660 510(k)

888.3650 GUDID

878.4800 GUDID

Market of Registration

Spain

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

Sterilization Method

Moist Heat or Steam Sterilization

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  CE/MDR MDR 777490 Active Valid to Sep 2031

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  CE/MDR MDR 777490 Active Valid to Sep 2031

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  Class III

  CE/MDR MDR 777490 Active Valid to Sep 2031

See all devices from Exactech, Inc. →

• What types of surgical procedures is the Equinoxe Central Screw Baseplate System intended for?

  The Equinoxe Central Screw Baseplate System is specifically designed for use in reverse total shoulder arthroplasty, a procedure where the shoulder joint is replaced to restore function and alleviate pain in patients with severe shoulder arthritis or injuries.

• Is the Equinoxe Central Screw Baseplate System reusable or single-use?

  The system is explicitly intended for single-use in orthopedic settings, as stated in the manufacturer’s specifications. This ensures sterility and reduces the risk of cross-contamination.

• What key features of the Equinoxe Central Screw Baseplate System enhance its fixation in surgery?

  The baseplate features a curved, anatomical design with a central compression screw and peripheral screws, which work together to improve fixation and bone preservation during reverse total shoulder arthroplasty. Additionally, it includes a cylindrical bone cage to support structural integration.

• How is the Equinoxe Central Screw Baseplate System supplied, and what does this mean for surgical planning?

  The system is supplied sterile, meaning it is ready for immediate use in the operating room without additional sterilization. This simplifies surgical workflows and ensures compliance with infection control protocols.

• What regulatory pathways has the Equinoxe Central Screw Baseplate System followed for approval?

  The device has received FDA 510(k) clearance under the classification K233482, with a decision described as ‘Substantially Equivalent’ to predicate devices, and it also meets the requirements of the EU Medical Device Regulation (MDR).