The Recall Desk

FDA (Devices) recall action 97588

Exactech, Inc. recalled 3 products on 2025-11-26

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2025-11-26
Critical
0
Units
3

Why these products were recalled

Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.

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

1–3 of 3

  • ModerateFDA (Devices)··2025-11-26

    Shoulder reamers recalled after release without completed performance testing

    Exactech is recalling one Equinoxe Ergo Adjustable Angle rTSA Reamer, 42mm, because it was released before design updates and performance testing were completed.

    Product
    Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product Description: rTSA Reamer, 42mm Component: Not a component
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2025-11-26

    Shoulder reamer 46mm recalled after release without completed performance testing

    Exactech is recalling one Equinoxe Ergo Adjustable Angle rTSA Reamer, 46mm, because it was released before design updates and performance testing were completed.

    Product
    Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product Description: rTSA Reamer, 46mm Component: Not a component
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2025-11-26

    Pilot tip converters recalled after release without completed performance testing

    Exactech is recalling one Equinoxe Ergo Augments Pilot Tip Converter because it was released before design updates and performance testing were completed.

    Product
    Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Description: Pilot Tip Converter Piece Component: Not a component
    Category
    Distribution
    1 state