Equinoxe 320-40-13Recalls & reported problems
Exactech, Inc. · Constrained Humeral Liner · 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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862535061), received between Nov 15, 2024 and Sep 25, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Naturally Worn” (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 16, 2026.
Reports received per month
Recalls naming this device
- Mar 6, 2024Open, 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 ↗
Most reported problems
Device problems
- Naturally Worn2
- Detachment of Device or Device Component1
- Unstable1
Patient problems
- Joint Laxity2
- Bone Notching1
- Joint Dislocation1
- Joint Impingement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2025Detachment of Device or Device Component; Naturally Worn; Detachment of Device or Device Component; Naturally Worn
AS REPORTED, APPROXIMATELY 2 YEARS POST THE INITIAL RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO DISLOCATION. THE PATIENT INDICATED NO TRAUMA OCCURRED. THE SURGEON OBSERVED THE POLYETHYLENE COMPONENT DISSOCIATED FROM THE TRAY AND FLIPPED OVER. NO ABNORMAL WEAR WAS NOTED ON THE FACE OF THE POLYETHYLENE COMPONENT THAT MIGHT AFFECT THE LOCKING MECHANISM OF THE POLYETHYLENE LINER TO THE TRAY. THE SURGEON REPORTED THERE COULD HAVE POSSIBLY BEEN AN ISSUE WITH THE LOCKING MECHANISM OF THE POLY. THE SURGEON REPORTED IT WAS ALSO POSSIBLE THE POLY WASN'T IMPACTED FIRMLY ENOUGH ON THE INITIAL SURGERY. THE PATIENT WAS REVISED TO 40 +2.5 CONSTRAINED LINER. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Joint Dislocation
MAUDE report 23148676 ↗InjuryAug 4, 2025Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL REVERSE TOTAL SHOULDER REPLACEMENT ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED INSTABILITY AND BONE NOTCHING. AS A RESULT, APPROXIMATELY TWO YEARS AND THREE-MONTHS POST-SURGERY, THE PATIENT UNDERWENT A REVISION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 2 FOR THIS EVENT/PATIENT.
Patient problems: Bone Notching; Joint Impingement; Joint Laxity
MAUDE report 22698945 ↗InjuryNov 15, 2024Unstable; Unstable
AS REPORTED, THE PATIENT UNDERWENT A THIRD RIGHT SIDE SHOULDER REVISION SURGERY DUE TO INSTABILITY AFTER HER REVERSE REPLACEMENT. THE HUMERAL TRAY WAS REVISED FROM A 0 TO A +10. THE POLY WAS ALSO REVISED TO A CONSTRAINED LINER. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.
Patient problems: Joint Laxity
MAUDE report 20694905 ↗
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- 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 · 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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