Equinoxe 321-35-23Recalls & reported problems

Exactech, Inc. · INSERTER, SMALL GLENOID PLATE, SPRING-LOADED · Class 2

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862566355), received between Aug 22, 2023 and Aug 22, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

13 other recalls cover devices cleared under the same FDA submission (K063569); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

Break1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryAug 22, 2023Break; Break
IT WAS REPORTED THAT DURING SURGICAL USE, THE PIN FELL OUT AND WAS DISASSEMBLED. NO PARTS OR PIECES FELL INTO THE PATIENT WOUND SITE. NO SURGICAL DELAY/PROLONGATION. NO PATIENT INFORMATION PROVIDED. DEVICE IS RETURNING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17595291 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063569. One submission often covers many models, so check the product and lot details in each record.

Z-2561-2025 · Aug 15, 2025 · Open, Classified
Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0/
Z-1424-2024 · Mar 6, 2024 · Open, Classified
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
Z-1422-2024 · Mar 6, 2024 · Open, Classified
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
Z-1425-2024 · Mar 6, 2024 · Open, Classified
Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoulder Arthroplasty
Z-1423-2024 · Mar 6, 2024 · Open, Classified
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
Z-1418-2024 · Mar 6, 2024 · Open, Classified
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
Z-1419-2024 · Mar 6, 2024 · Open, Classified
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
Z-0579-2024 · Nov 21, 2023 · Open, Classified
Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d) 320-36-10, e) 320-36-13, f) 320-38-00, g) 320-38-13, h) 320-40-00,
Z-3020-2020 · Aug 24, 2020 · Terminated
Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.
Z-3019-2020 · Aug 24, 2020 · Terminated
Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.
Z-0012-2019 · Aug 21, 2018 · Open, Classified
Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
Z-0900-2017 · Oct 25, 2016 · Terminated
Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit
Z-2117-2012 · Jun 15, 2012 · Terminated
Equinoxe Reverse Compression Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.

Device details

UDI-DI	`10885862566355`
Brand	Equinoxe
Model	321-35-23
Company	Exactech, Inc.
Product code	KWT · PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
Class	Class 2
FDA submission	K063569
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 11, 2024

Device type (GMDN): Orthopaedic inorganic implant inserter/extractor, reusable

A hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a reusable device.

Other PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED devices

Equinoxe 320-38-00
Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
3 recalls107 reports
Equinoxe 320-42-00
Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
3 recalls107 reports
Equinoxe 320-42-03
Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
2 recalls87 reports
Equinoxe 320-38-03
Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
2 recalls43 reports
Equinoxe 320-42-13
Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
2 recalls41 reports
Equinoxe 320-10-00
Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
132 reports
Equinoxe 320-36-00
Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
2 recalls27 reports
Equinoxe 320-42-10
Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
2 recalls14 reports

All PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.