Encore Medical, LP 2025-07-23 Health serious FDA
Health · FDA · Recall #FDA-Z-2126-2025
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS,… Recall
Issued July 23, 2025 · Encore Medical, LP
In July 2025, Encore Medical, LP recalled the Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS,…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 you should do
- 1 Stop using Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS,… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Encore Medical, LP to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Encore Medical, LP
- Category
- Health
- Recall date
- July 23, 2025
- Units affected
- Not reported
- Sold at
- 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
- Recall number
- FDA-Z-2126-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Encore Medical, LP has 6 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.