Equinoxe 304-22-11Recalls & 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 10885862083401), received between Apr 21, 2025 and Apr 21, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Loosening of Implant Not Related to Bone-Ingrowth1

Patient problems

Aseptic loosening1
Joint Dislocation1
Loss of Range of Motion1

Recent adverse event reports

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

InjuryApr 21, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A 52 YO MALE PATIENT, INITIAL RIGHT SHOULDER IMPLANTED IN (B)(6) 2024, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2025. THE PATIENT HAD BEEN DISLOCATING AND HAD LIMITED RANGE OF MOTION DUE TO NON-COMPLIANCE OF EXERCISE. DURING THE PROCEDURE THE STEM WAS FOUND TO BE LOOSE. CEMENT WAS ON THE IMPLANT ONLY AND NOT ON THE BONY INTERFACE. THE SURGEON USED THE SAME SIZE STEM AS PREVIOUSLY INSERTED. THE GLENOID WAS CHANGED AS THE SURGEON WANTED A LARGER SURFACE AREA TO PREVENT DISLOCATION. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE ABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. THEY WERE DISPOSED OF BY THE HOSPITAL. NO IMAGES WERE AVAILABLE. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS. SEE MDR# 1038671-2025-01866.
Patient problems: Aseptic loosening; Joint Dislocation; Loss of Range of Motion
MAUDE report 21877647 ↗

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-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-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-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
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

Device details

UDI-DI	`10885862083401`
Brand	Equinoxe
Model	304-22-11
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.

How reports and recalls are matched · Editorial policy · Report an error on this page