Equinoxe 314-06-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862228338), received between May 17, 2024 and May 17, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K121220); 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.

Recalls naming this device

1. 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-1410-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 17, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, APPROXIMATELY TEN YEARS POST INITIAL LEFT TSA, THE 73 Y/O MALE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING. THE PATIENT COMPLAINING OF INCREASING SHOULDER PAIN ESPECIALLY WITH OVERHEAD ACTIVITIES. ASEPTIC GLENOID COMPONENT LOOSENING. PATIENT IS SCHEDULED A COMPUTED TOMOGRAPHY (CT) AND THE EVENT STILL ONGOING. PER CLINICAL REPORT, THE REPORTED EVENT IS POSSIBLY RELATED TO THE DEVICE AND UNLIKELY RELATED TO PROCEDURE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 19341371 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121220. One submission often covers many models, so check the product and lot details in each record.

• Z-1411-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-06-32, b) 41, 44, 47, 50 head,