Equinoxe 320-36-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862086648), received between Jan 9, 2024 and Jan 9, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

1 other recall cover devices cleared under the same FDA submission (K093275); 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-1417-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. Nov 21, 2023Open, 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

Recent adverse event reports

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

• InjuryJan 9, 2024Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE PATIENT HAD AN INITIAL LEFT TSA ON (B)(6)2020. THE PATIENT PRESENTED ON (B)(6) 2020 INSTABILITY / SUBLUXATION. PATIENT REPORTS ONGOING SUBLUXATION EVENTS, UP TO 4-5 TIMES PER WEEK. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO DEVICE AND/ TO PROCEDURE. OUTCOME IS RESOLVED ON (B)(6) 2021. SYMPTOMS RESOLVED WITH STRENGTHENING AND TIME. NO DEVICE RETURN ANTICIPATED DUE TO BEING A CLINICAL TRIAL STUDY. EBI INITIAL SURGERY ATTACHED.

  Patient problems: Failure of Implant; Subluxation

  MAUDE report 18477235 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093275. One submission often covers many models, so check the product and lot details in each record.

• Z-1416-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty