The Recall Desk

FDA (Devices) recall action 97188

Encore Medical, LP recalled 2 products on 2025-08-20

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
2025-08-20
Critical
0
Units
58

Why these products were recalled

Knee implants contain incorrect labeling (size and/or side incorrect)

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)··2025-08-20

    Knee tibial insert catalog number 341-16-704 recalled for mislabeled size or side

    Enovis is recalling 18 EMPOWR 3D Knee tibial inserts, catalog number 341-16-704, lot 148T1057, because the implants carry incorrect size or side labeling.

    Product
    Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 Product Description: Enovis knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use.
    Category
    Distribution
    13 states
  • HighFDA (Devices)··2025-08-20

    EMPOWR 3D knee tibial inserts recalled over incorrect size or side labeling

    Enovis is recalling 40 EMPOWR 3D Knee tibial inserts, catalog number 342-16-707, because the implants carry incorrect size or side labeling.

    Product
    Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE Model/Catalog Number: 342-16-707 Product Description: Enovis knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use.
    Category
    Distribution
    13 states