Equinoxe 304-22-13Recalls & reported problems

Exactech, Inc. · Class 2 · Implant

All models of Equinoxe (305)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 10885862083418), received between Sep 1, 2023 and Sep 1, 2023 — classified as 1 injury.

4 other recalls cover devices cleared under the same FDA submission (K092900, K101909); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1

Patient problems

Bone Fracture(s)1
Periprosthetic fracture1

Recent adverse event reports

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

InjurySep 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED, APPROXIMATELY ONE YEAR POST INITIAL RIGHT TSA, THE 63 Y/O FEMALE PATIENT HAD A REVISION DUE TO PERIPROSTHETIC FRACTURE PATIENT'S STEM, ADAPTER TRAY AND LINER WERE EXCHANGED. SURGEON USED A HRP TO REBUILD THE HUMERUS. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN PHOTOS/X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY WERE DISPOSED AT THE HOSPITAL. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.
Patient problems: Bone Fracture(s); Periprosthetic fracture
MAUDE report 17671576 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092900, K101909. One submission often covers many models, so check the product and lot details in each record.

Z-0308-2021 · Sep 25, 2020 · Terminated
Equinoxe Platform Fracture Stem, 6.5mm, Right - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
Z-0307-2021 · Sep 25, 2020 · Terminated
Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
Z-0872-2020 · Dec 3, 2019 · Terminated
Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 6.5mm, REF 304-22-07 - Product Usage: The Equinoxe Shoulder System is indicated for use and in skeletally mature
Z-0873-2020 · Dec 3, 2019 · Terminated
Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 10.5mm, REF 304-22-11 - Product Usage: The Equinoxe Shoulder System is indicated for use and in skeletally matur

Device details

UDI-DI	`10885862083418`
Brand	Equinoxe
Model	304-22-13
Company	Exactech, Inc.
Product code	KWT · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Class	Class 2
FDA submission	K092900, K101909
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 6, 2018

Device type (GMDN): Partial shoulder prosthesis

A sterile implantable artificial substitute for the humeral component of a shoulder joint typically replaced due to injury (e.g., fracture). It includes humeral head and stem components with parts made of metal and can articulate with the natural glenoid fossa, a glenoid fossa prosthesis, or a humeral head bipolar component. Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.

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 and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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