Equinoxe 300-30-15Recalls & reported problems
Exactech, Inc. · Class 2 · Implant
All models of Equinoxe (305)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862515834), received between Oct 2, 2024 and Oct 2, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Naturally Worn” (1 report).
1 other recall cover devices cleared under the same FDA submission (K162726); 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Naturally Worn1
Patient problems
- Implant Pain1
- Loss of Range of Motion1
- Metal Related Pathology1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 2, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THIS PATIENT HAD A RIGHT REVERSE SHOULDER PUT IN 2020. REVISED AGAIN IN 2021 BY A LOCAL ORTHOPEDIC SURGEON. THEN PATIENT SAW A DIFFERENT SURGEON WHO REVISED THE PATIENT AND TOOK OUT HUMERAL COMPONENTS AND GLENOSPHERE AND REPLACED. THERE WAS A LOT OF METALLOSIS AND THE TRAY WAS COMPLETELY SHEERED OFF THE STEM. THE STEM HAD OVERSTUFFED THE JOINT, A 15 PRESERVE STEM WAS USED. THE SURGEON COULD NOT FIND THE LINER POLY FROM THE ORIGINAL SURGERY. SURGEON CHECKED AROUND THE JOINT FOR IT AS WELL AS HIS PA AND ASSIST. NO ONE COULD FEEL FOR THE 46 +2.5MM LINER IN THE JOINT. PATIENT WAS REVISED TO A FX STEM AND A NEW GLENOSPHERE AND TRAY AND LINER. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT
Patient problems: Implant Pain; Loss of Range of Motion; Metal Related Pathology
MAUDE report 20351970 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K162726. One submission often covers many models, so check the product and lot details in each record.
- Z-0958-2019 · Dec 5, 2018 · TerminatedEquinoxe Preserve Humeral Stem, 8mm Product Usage: The Equinoxe Preserve Stems are indicated for use in skeletally mature individuals with degenerative diseases of the glenohum
Other Shoulder Prosthesis, Reverse Configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 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
- 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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