Equinoxe® 322-40-00Recalls & reported problems
Exactech, Inc. · Humeral Liner · Class 2 · Implant
All models of Equinoxe (305)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862593870), received between Aug 12, 2024 and Mar 17, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).
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
- Device Dislodged or Dislocated2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Joint Dislocation2
- Bone Fracture(s)1
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem
AS REPORTED BY THE EQUINOXE SHOULDER STUDY, DURING AN INITIAL RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY, A SMALL CALCAR SPLIT OCCURRED WHILE IMPACTING THE HUMERAL COMPONENT. THE PROXIMAL HUMERUS WAS CERCLAGED X2 WITH 2 NICE LOOPS OF #5 ETHIBOND. THE OUTCOME IS CONSIDERED TO BE RESOLVED.
Patient problems: Bone Fracture(s)
MAUDE report 24616094 ↗InjuryJan 12, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT A MALE PATIENT, WHO HAD A RIGHT RTSA, UNDERWENT A REVISION PROCEDURE. THE PATIENT DISLOCATED. THE SURGEON EXCHANGED THE 40+0 LINER TO A 40+0 CONSTRAINED LINER. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE ABLE TO BE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN AS THE FACILITY IS HOLDING THE PRODUCT. NO DEVICE IMAGES WERE AVAILABLE. NO FURTHER INFORMATION.
Patient problems: Joint Dislocation
MAUDE report 24047200 ↗InjuryAug 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THIS PATIENT'S LEFT SHOULDER HAD DISLOCATED. SURGEON WENT IN AND DID A THOROUGH DEBRIDEMENT, THEN SWITCHED OUT THE +0 LINER FOR A NEW 40MM +0 CONSTRAINED LINER. IMPLANT FAILED A FEW WEEKS POST OP. UNABLE TO OBTAIN IMAGES OR X-RAYS. NO ADDITIONAL PATIENT/MEDICAL INFORMATION PROVIDED.
Patient problems: Insufficient Information; Joint Dislocation
MAUDE report 19968850 ↗
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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