Reported Aug 20, 2025 · Ongoing
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE Model/Catalog Number:…
Encore Medical, LP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Encore Medical, LP · 9800 Metric Blvd · Austin, TX · 78758-5445
Is this the product you have?
- Brand NameEMPOWR 3D KNEE
- TIBIAL INSERT - E-PLUS Product Name
EMPOWR 3D KNEE INS7R 16MM
- VE Model/Catalog Number342-16-707
- Product DescriptionEnovis 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
- Lot codes and dates
- Lot CodeItem: 342-16-707
- GTIN00888912167642
- Lot
161T1053161T1054
- Amount recalled
- 40 implants
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Knee implants contain incorrect labeling (size and/or side incorrect)
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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