Equinoxe® 322-36-10Recalls & reported problems
Exactech, Inc. · Humeral Liner, Constrained · Class 2 · Implant
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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862593818), received between Jul 13, 2026 and Jul 13, 2026 — 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 (K223833); 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
Most reported problems
Device problems
- Naturally Worn1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 13, 2026Naturally Worn
IT WAS REPORTED THAT A PATIENT, WHO HAD RIGHT RTSA, UNDERWENT A REVISION PROCEDURE. THE PATIENT REPORTED HAVING PAIN SINCE THEIR SURGERY. THEY INDICATED THAT NO INJURY HAD OCCURRED. IT WAS OBSERVED THAT THE BASEPLATE AND GLENOSPHERE WERE DISLODGED FROM THE GLENOID. THE GLENOID COMPONENTS, HUMERAL TRAY, & LINER WERE REMOVED. THE CONSTRUCT WAS CONVERTED TO A HEMIARTHROPLASTY. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. AN X-RAY WAS PROVIDED. DEVICE MIGRATION WAS OBSERVED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. A PHOTO OF THE DEVICES WAS PROVIDED. PROSTHESIS WEAR WAS OBSERVED. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.
Patient problems: Pain
MAUDE report 25807963 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K223833. One submission often covers many models, so check the product and lot details in each record.
- Z-2562-2025 · Aug 15, 2025 · Open, ClassifiedExactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINER +2.5), REF:322-42-00 (145-DEG PE 42MM HUM L
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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