FDAFDA · Food and drugs·Recall number Z-2286-2025
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. While total knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.
Published August 20, 2025 · Recall initiated: July 9, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Knee implants contain incorrect labeling (size and/or side incorrect)
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Encore Medical, LP
- Distributor
- US Nationwide distribution in the states of AL, AZ, CA, CO, FL, IA, IL, IN, KS, LA, NY, TN, TX.
- Lot
- Lot Code: Item: 342-16-707 GTIN: 00888912167642 Lot: 161T1053, 161T1054
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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