Equinoxe 320-40-10Recalls & reported problems
Exactech, Inc. · Constrained Humeral Liner · Class 2 · Implant
All models of Equinoxe (305)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name 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
- 2
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862535054), received between Oct 21, 2024 and Oct 21, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Naturally Worn” (1 report).
2 FDA recall records name this device's identifier, 2 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
- Mar 6, 2024Class IIOpen, Classified
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).
Z-1421-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- 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-0579-2024 · Root cause: Packaging change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Naturally Worn1
Patient problems
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 21, 2024Naturally Worn; Naturally Worn
AS REPORTED, APPROXIMATELY 1 YEAR AND 10 MONTHS POST LEFT TOTAL SHOULDER ARTHROPLASTY (TSA), THE HUMERAL RECONSTRUCTION PROSTHESIS (HRP) AND REVERSE BASEPLATE WERE REMOVED DUE TO INFECTION. A G21 MOLDED ANTIBIOTIC SPACER WAS IMPLANTED. IT WAS FURTHER STATED THAT THERE WAS POLY/LINER WEAR. IT WAS UNCLEAR IF THE DEVICE "BROKE" DUE TO INFECTION OR VICE VERSA. LABS WERE TO DETERMINE WHAT WAS INFECTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.
Patient problems: Unspecified Infection
MAUDE report 20496978 ↗
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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