Equinoxe 310-01-47Recalls & reported problems

Exactech, Inc. · Humeral Head, Short · 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 10885862657589), received between Sep 2, 2026 and Sep 2, 2026 — classified as 1 injury.

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

10 other recalls cover devices cleared under the same FDA submission (K042021); 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

Naturally Worn1

Patient problems

Metal Related Pathology1

Recent adverse event reports

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

InjurySep 2, 2026Naturally Worn
Patient problems: Metal Related Pathology
MAUDE report 50563623 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042021. One submission often covers many models, so check the product and lot details in each record.

Z-0537-2026 · Sep 5, 2025 · Open, Classified
Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Description: Pilot Tip Converter Piece Compo
Z-0535-2026 · Sep 5, 2025 · Open, Classified
Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product Description: rTSA Reamer, 42mm Component: N
Z-0536-2026 · Sep 5, 2025 · Open, Classified
Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product Description: rTSA Reamer, 46mm Component: N
Z-1405-2024 · Mar 6, 2024 · Open, Classified
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02
Z-1403-2024 · Mar 6, 2024 · Open, Classified
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Nu
Z-1404-2024 · Mar 6, 2024 · Open, Classified
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Nu
Z-1402-2024 · Mar 6, 2024 · Open, Classified
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item
Z-0884-2021 · Nov 9, 2020 · Open, Classified
Equinoxe Humeral Stem, Primary, Press Fit, 11mm
Z-1459-2015 · Feb 13, 2015 · Terminated
Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component.
Z-2115-2012 · Jun 15, 2012 · Terminated
Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty

Device details

UDI-DI	`10885862657589`
Brand	Equinoxe
Model	310-01-47
Company	Exactech, Inc.
Product code	HSD · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
Class	Class 2
FDA submission	K042021
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	Sep 17, 2025

Device type (GMDN): Shoulder humeral body prosthesis

A sterile implantable component of a total shoulder prosthesis intended to form a connection between a humeral stem prosthesis and a humeral head prosthesis. It is made of metal [e.g., cobalt-chrome-molybdenum (Co-Cr-Mo)] or titanium (Ti)] and is used in a modular shoulder replacement system.

Other PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED devices

DJO SURGICAL 509-02-032
Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
364 reports
DELTA XTEND 130790036
Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
171 reports
DELTA XTEND 130770018
Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
159 reports
TRIGEN 71118200
Smith & Nephew, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
123 reports
DJO SURGICAL 509-02-432
Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
119 reports
DELTA XTEND 130738206
Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
116 reports
COMPREHENSIVE SHOULDER SYSTEM 113633
Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
2 recalls4 reports
DELTA XTEND 130742206
Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
99 reports

All PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED 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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