Equinoxe 314-24-23Recalls & reported problems
Exactech, Inc. · Class 2 · Implant
All models of Equinoxe (305)
Data updated Oct 16, 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862585356), received between Jan 14, 2025 and Jan 14, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 16, 2026.
Reports received per month
Recalls naming this device
- Nov 21, 2023Open, 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
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Muscle Weakness/Atrophy1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 14, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A MALE PATIENT, INITIAL LEFT SHOULDER IMPLANTED ON (B)(6) 2024, WAS CONVERTED TO A REVERSE ON AN UNKNOWN DATE. THE PATIENT¿S SHOULDER WAS VERY STIFF. FOLLOWING THE PATIENT¿S INDEX SURGERY, HE DEVELOPED SOME DELTOID ATROPHY AND SHOWED SOME SUPRASCAPULAR AND AXILLARY NERVE ATROPHY ON EMG. THE SURGEON DECIDED TO CONVERT TO REVERSE. THE EVENT HAPPENED SOMETIME TOWARDS THE END OF THE YEAR. THE HEAD, REPLICATOR PLATE, AND TORQUE SCREW WERE REMOVED. THE STEM WAS WELL FIXED AND RETAINED. THE LASER CAGE GLENOID WAS LOOSE AND ABLE TO BE PULLED OUT WITH A RONGEUR. A POSTERIOR BASEPLATE, 2 34MM SCREWS, 1 30MM SCREW, 38MM EXPANDED SPHERE, LOCKING SCREW, 38MM 0MM LINER, 0MM TRAY, AND REVERSE TORQUE SCREW WERE IMPLANTED. CULTURES WERE TAKEN. THERE WERE NO DEVICE BREAKAGES DURING THE PROCEDURE. THERE WAS LESS THAN A 45-MINUTE DELAY DURING THE PROCEDURE, WITH NO ADVERSE EVENT TO THE PATIENT. THE DELAY WAS IN REFERENCE TO THE NEED FOR A REVISION SURGERY AT ALL. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS WERE PROVIDED. THE EXPLANTED PRODUCT IS AVAILABLE FOR RETURN. IMAGES WERE PROVIDED. NO FURTHER INFORMATION.
Patient problems: Muscle Weakness/Atrophy
MAUDE report 21151933 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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