The Recall Desk

FDA (Devices) recall action 97459

Exactech, Inc. recalled 2 products on 2025-09-24

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
2025-09-24
Critical
0
Units
72,876

Why these products were recalled

Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.

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

  • HighFDA (Devices)··2025-09-24

    Reverse shoulder liners recalled over articular surface outside dimensional specification

    Exactech Equinoxe Reverse Shoulder humeral liners under REF 320-38 and 320-42 are recalled because the articular surface position falls outside the dimensional specification in the labeling. 61,334 units are affected.

    Product
    Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0/ 320-42-03,145-DEG PE 42MM HUM LINER +2.5/
    Category
    Distribution
    25 states
  • HighFDA (Devices)··2025-09-24

    Shoulder humeral liners recalled over articular surface outside dimensional specification

    Exactech Equinoxe Reverse Shoulder humeral liners in 38 mm and 42 mm sizes are recalled because the articular surface position falls outside the dimensional specification in the labeling. 11,542 units are affected.

    Product
    Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINER +2.5), REF:322-42-00 (145-DEG PE 42MM HUM LINER +0), REF: 322-42-03 (145-DEG PE 42MM HUM LINER +2.5)
    Category
    Distribution
    25 states