Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE Model/Catalog…

Is this the product you have?

• Brand NameEMPOWR 3D KNEE
• TIBIAL INSERT - E-PLUS Product Name
  • EMPOWR 3D KNEETM INS
  • 11L 12MM
• VE Model/Catalog Number341-12-711
• Software VersionNA
• 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
• ComponentNA

Lot codes and dates

• Lot CodeItem: 341-12-711
• GTIN00888912166980
• Lot115T1077

Amount recalled

20

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

• Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS…

Where it was sold

• AZ
• IA
• ID
• IL
• IN
• LA
• MI
• MO
• MS
• NE
• NY
• OK
• OR
• PR
• SD
• UT
• VA
• WA

Why it was recalled

Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used.

This product could cause temporary or reversible health problems — stop using it.