Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 7R 16MM, VE Model/Catalog Number: 342-16-707 Software Version: NA 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. Compone
Reported: August 20, 2025 Initiated: July 9, 2025 #Z-2286-2025
Product Description
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 7R 16MM, VE Model/Catalog Number: 342-16-707 Software Version: NA 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. Component: NA
Reason for Recall
Knee implants contain incorrect labeling
Details
- Recalling Firm
- Encore Medical, LP
- Units Affected
- 40 implants
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, CO, FL, IA, IL, IN, KS, LA, NY, TN, TX.
- Location
- Austin, TX
Frequently Asked Questions
What product was recalled? ▼
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 7R 16MM, VE Model/Catalog Number: 342-16-707 Software Version: NA 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. Component: NA. Recalled by Encore Medical, LP. Units affected: 40 implants.
Why was this product recalled? ▼
Knee implants contain incorrect labeling
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 20, 2025. Severity: Moderate. Recall number: Z-2286-2025.
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