Equinoxe® 322-38-00Recalls & reported problems
Exactech, Inc. · Humeral Liner · 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 10885862593832), received between Feb 5, 2025 and Sep 8, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).
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
- Aug 15, 2025Class IIOpen, Classified
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
Z-2562-2025 · Root cause: Process design · Recall details · FDA record ↗
Most reported problems
Device problems
- Device Dislodged or Dislocated2
Patient problems
- Joint Dislocation2
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 8, 2026Device Dislodged or Dislocated
It was reported that the patient underwent a left shoulder replacement. Subsequently, the patient experienced a dislocation. As a result, a revision was performed during which the surgeon exchanged the existing liner for a thicker constrained liner. The patient was last known to be in stable condition following the event. No further information is available.
Patient problems: Joint Dislocation
MAUDE report 50670421 ↗InjuryFeb 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT A 70 YO FEMALE PATIENT, INITIAL REVERSE LEFT SHOULDER IMPLANTED IN (B)(6) 2024, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2025, APPROXIMATELY 3 MONTHS POST THE INITIAL PROCEDURE. THE SURGEON EXPLANTED THE GLENOSPHERE, TRAY AND LINER AND WENT BACK IN WITH NEW ONES. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE AVAILABLE FOR RETURN. A DEVICE IMAGE WAS PROVIDED. NO FURTHER INFORMATION.
Patient problems: Insufficient Information; Joint Dislocation
MAUDE report 21316008 ↗
Other PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED devices
- Equinoxe 320-42-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-38-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls87 reports
- Equinoxe 320-38-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls43 reports
- Equinoxe 320-42-13Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls41 reports
- Equinoxe 320-10-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented132 reports
- Equinoxe 320-36-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls27 reports
- Equinoxe 320-42-10Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls14 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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