The Recall Desk

FDA (Devices) recall action 97094

Encore Medical, LP recalled 2 products on 2025-07-30

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
2025-07-30
Critical
0
Units
40

Why these products were recalled

Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.

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)··2025-07-30

    EMPOWR dual mobility poly bearings were packaged with the wrong implant

    EMPOWR Acetabular Dual Mobility Poly Bearings are being recalled because of a packaging discrepancy in which incorrect implants were packaged, discovered through a customer complaint. 20 units affected.

    Product
    Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 Model/Catalog Number: 952-28-40E Software Version: NA Product Description: The EMPOWR Dual Mobility" system is compatible with the EMPOWR Acetabular¿ system, 28mm femora
    Category
    Distribution
    14 states
  • HighFDA (Devices)··2025-07-30

    EMPOWR dual mobility OD42 bearings were packaged with the wrong implant

    EMPOWR Acetabular Dual Mobility Poly Bearings, catalog number 952-28-42F, are being recalled because of a packaging discrepancy in which incorrect implants were packaged. 20 units affected.

    Product
    Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 Model/Catalog Number: 952-28-42F Software Version: NA Product Description: The EMPOWR Dual Mobility" system is compatible with the EMPOWR Acetabular¿ system, 28mm femora
    Category
    Distribution
    14 states