Equinoxe 321-07-00Recalls & reported problems

Exactech, Inc. · INSERTER, STEM, REVERSE SHOULDER · Class 2

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: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862243034), received between Jun 1, 2021 and Jun 1, 2021 — classified as 1 malfunction.

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

23 other recalls cover devices cleared under the same FDA submission (K042021, K061454, 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

MalfunctionJun 1, 2021Break; Break
AS REPORTED, THE SURGEON WAS REMOVING THE BROACH WHEN THE ROD SNAPPED OFF. SURGEON DID NOT HIT VERSION ROD IN PROCESS. THREADED END OF THE ROD WAS SHEERED OFF IN BROACH HANDLE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11914084 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042021, K061454, K063569. 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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,

…and 8 more.

Device details

UDI-DI	`10885862243034`
Brand	Equinoxe
Model	321-07-00
Company	Exactech, Inc.
Product code	KWT · PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
Class	Class 2
FDA submission	K042021, K061454, 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 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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