FDA Medical devices recall · July 23, 2025

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

Read the official FDA notice ↗

Product

Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE Model/Catalog Number: 341-12-711 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

Why was it 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.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

Lot Code: Item: 341-12-711 GTIN: 00888912166980 Lot: 115T1077

Distribution

U.S Distribution to states of: AZ, IA, ID, IL, IN, LA, MI, MO, MS, NE, NY, OK, OR, PR, SD, UT, VA, and WA

States: Arizona Iowa Idaho Illinois Indiana Louisiana Michigan Missouri Mississippi Nebraska New York Oklahoma Oregon Puerto Rico South Dakota Utah Virginia Washington

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-2126-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.