Equinoxe 321-09-38Recalls & reported problems

Exactech, Inc. · Humeral Liner Impactor Tip 38mm · Class 2

All models of Equinoxe (305)

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

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862558558), received between Nov 14, 2022 and Aug 5, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

13 other recalls cover devices cleared under the same FDA submission (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.

Reports received per month

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

Most reported problems

Device problems

Break2

Patient problems

Insufficient Information1
No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 5, 2024Break; Break
IT WAS REPORTED THAT DURING SURGICAL USE, "THE LINER IMPACTOR TIP HAS BROKEN UNDER IMPACTION FORCE." NO PATIENT INFORMATION AVAILABLE. THE DEVICE IS AVAILABLE FOR RETURN. NO FURTHER DETAILS PROVIDED. UNABLE TO OBTAIN IMAGES OR X-RAYS. PRODUCT AVAILABLE FOR RETURN: RG REQUESTED. 321-09-38 38MM LINER IMPACTOR TIP.
Patient problems: Insufficient Information
MAUDE report 19913793 ↗
MalfunctionNov 14, 2022Break; Break
AS REPORTED, DURING IMPACTION, THE IMPACTION TIP BROKE INTO TWO (2) PIECES WHEN IMPACTED. THERE WAS NO SURGICAL DELAY/PROLONGATION. SALES REP WAS UNABLE TO OBTAIN PHOTOS/X-RAYS. THE DEVICE WILL BE RETURN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15789232 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063569. One submission often covers many models, so check the product and lot details in each record.

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-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-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-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-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-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,
Z-3019-2020 · Aug 24, 2020 · Terminated
Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.
Z-3020-2020 · Aug 24, 2020 · Terminated
Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.
Z-0012-2019 · Aug 21, 2018 · Open, Classified
Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
Z-0900-2017 · Oct 25, 2016 · Terminated
Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit
Z-2117-2012 · Jun 15, 2012 · Terminated
Equinoxe Reverse Compression Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.

Device details

UDI-DI	`10885862558558`
Brand	Equinoxe
Model	321-09-38
Company	Exactech, Inc.
Product code	KWT · PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
Class	Class 2
FDA submission	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	Feb 9, 2026

Device type (GMDN): Orthopaedic implant impactor, reusable

A non-powered, hand-held, surgical instrument designed to transmit impact forces, typically from a hammer/mallet to an orthopaedic implant (e.g., intramedullary nail or stem), to position/drive the implant into the body during impact-based implantation. It commonly includes an impact-absorbing handle with a distal end shaped to conform to the implant (i.e., flat or anatomically curved). 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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