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Equinoxe 320-36-10Recalls & reported problems

Exactech, Inc. · Class 2 · Implant

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
2

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862086631), received between Sep 29, 2023 and Sep 29, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 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 · 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 · FDA record ↗

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Fracture1

Patient problems

  • Bone Fracture(s)1

Recent adverse event reports

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

  • InjurySep 29, 2023Fracture; Fracture; Adverse Event Without Identified Device or Use Problem

    AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6) 2019. THE PATIENT PRESENTED ON (B)(6) 2019 AND POST OP SCAPULA FX. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO DEVICE, DEFINITELY RELATED TO PROCEDURE.

    Patient problems: Bone Fracture(s)

    MAUDE report 17842039 ↗

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

Other Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented devices

All Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.