FDAHealthJuly 9, 2025
Encore Medical, LP — 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 int
⚠️ Knee implants contain incorrect labeling (size and/or side incorrect)
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 9, 2025
US Nationwide distribution in the states of AL, AZ, CA, CO, FL, IA, IL, IN, KS, LA, NY, TN, TX.
What's affected?
- 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. 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.
- Brand
- Encore Medical, LP
- Lot code
- Item:
Additional details
Lot Code: Item: 341-16-704 GTIN: 00888912167116 Lot\s: 148T1057
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 18 implants.
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