Equinoxe® 320-55-98Recalls & reported problems
Exactech, Inc. · Central Screw Baseplate One-Lock Kit · Class 2 · Implant
- 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 10885862630384), received between Jun 1, 2026 and Jun 1, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Joint Dislocation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 1, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT A PATIENT, WHO HAD A LEFT RTSA, UNDERWENT A REVISION PROCEDURE. FOLLOWING THE SURGERY ALL WAS WELL WITH THE PATIENT. ALMOST A MONTH AFTER THE INITIAL SURGERY, SHE REACHED BACK TO PUT THE LEGS UP ON HER RECLINER AND FELT A POP. X-RAYS CONFIRMED THE GLENOSPHERE HAD MOVED AND WASN'T FULLY SEATED. THE LOOSE GLENOSPHERE WAS REMOVED ALONG WITH THE LOCKING PLATE, CSB GLENOSPHERE LOCKING SCREW AND LINER. WE THEN REVISED WITH A NEW 36 GLENOSPHERE, CSB GLENOSPHERE SCREW, LOCKING PLATE/RING AND 36 LINER. 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. THE EXPLANTED DEVICES ARE NOT ABLE TO BE RETURNED. THE HOSPITAL DOES NOT ALLOW REMOVAL. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS
Patient problems: Joint Dislocation
MAUDE report 25352853 ↗
Other PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED devices
- Equinoxe 320-38-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-00Exactech, 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.