Equinoxe 314-23-14Recalls & reported problems
Exactech, Inc. · Class 2 · Implant
All models of Equinoxe (305)
Data updated Oct 18, 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862585325), received between Oct 5, 2023 and Dec 16, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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 18, 2026.
Reports received per month
Recalls naming this device
- Nov 21, 2023Class IIOpen, Classified
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Z-0580-2024 · Root cause: Packaging change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Fracture1
Patient problems
- Failure of Implant1
- Insufficient Information1
- Joint Dislocation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED VIA A SHOULDER STUDY, THAT A MALE PATIENT WHO HAD A STANDARD TOTAL W-STEMLESS SHOULDER REPLACEMENT, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 2 YEARS 9 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT HAD DISLOCATED HIS SHOULDER ON A PREVIOUS DATE. THE POLY HAD DISASSOCIATED. THE GLENOID, STEMLESS HUMERAL HEAD, AND STEMLESS HUMERAL CAGE WERE REPLACED. THE STUDY INDICATED THE EVENT WAS DEFINITELY NOT RELATED TO THE DEVICES OR THE PROCEDURE. OUTCOME AS RESOLVED. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.
Patient problems: Joint Dislocation
MAUDE report 23822454 ↗InjuryOct 5, 2023Fracture; Fracture
IT WAS REPORTED THAT THIS PATIENT'S SHOULDER HAD A BROKEN CAGE GLENOID, THIS WAS FOUND WHEN SURGEON WAS PERFORMING AN ARTHROSCOPY. PATIENT HAD BEEN COMPLAINING OF PAIN AFTER ANATOMIC TOTAL SHOULDER. GLENOID WAS REMOVED FROM PATIENT, REVISION SURGEON SET FOR LATER DATE. GLENOID HAS BEEN RETRIEVED AND WILL BE RETURNED TO EXACTECH.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 17877886 ↗
Other Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented devices
- DJO SURGICAL 508-32-204Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall544 reports
- Comprehensive Reverse Shoulder 010000589Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall142 reports
- DELTA XTEND 130738203Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED175 reports
- DJO SURGICAL 509-00-432Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall117 reports
- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 reports
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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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