The Recall Desk

FDA (Devices) recall action 78903

Exactech, Inc. recalled 2 products on 2018-02-07

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2018-02-07
Critical
0
Units
60

Why these products were recalled

Potentially mislabeled.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2018-02-07

    Exactech Recalls 30 Equinoxe Shoulder Implants Due to Mislabeling

    Exactech is recalling 30 Equinoxe shoulder implants because they may be mislabeled. The devices were distributed to facilities in 15 US states, Puerto Rico, and Switzerland.

    Product
    Equinoxe Cage, Glenoid, Alpha, Medium Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the p
    Category
    Distribution
    15 states
  • ModerateFDA (Devices)··2018-02-07

    Exactech Recalls 30 Mislabeled Equinoxe Shoulder Implant Components

    Exactech is recalling 30 Equinoxe Cage, Glenoid, Alpha, Small components due to potential mislabeling. The devices were distributed to facilities in 15 US states, Puerto Rico, and Switzerland.

    Product
    Equinoxe Cage, Glenoid, Alpha, Small Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the pr
    Category
    Distribution
    15 states