Equinoxe 314-01-12Recalls & reported problems

Exactech, Inc. · Class 2 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

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

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

9 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

Mar 6, 2024Open, Classified
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).
Z-1403-2024 · Root cause: Nonconforming Material/Component · FDA record ↗

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-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-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-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-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-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	`10885862084439`
Brand	Equinoxe
Model	314-01-12
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	Dec 23, 2019

Device type (GMDN): Shoulder glenoid fossa prosthesis, prefabricated

An implantable, prefabricated component of a total shoulder prosthesis (glenoid component) designed to replace or repair the glenoid fossa; it is not a custom-made device. It is cup-like in shape and typically made of polyethylene (PE), but may be made of metal or a combination of PE and metal; it may include fixation devices (e.g., screws) for attachment to the scapula.

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123 reports
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119 reports
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116 reports
COMPREHENSIVE SHOULDER SYSTEM 113633
Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
2 recalls4 reports
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Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
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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 13, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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