Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus Recalled by Encore Medical, LP Due to Packaging mixup; There is a potential that packaging...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Encore Medical, LP directly.
Affected Products
DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00888912166980
Quantity: 10 units
Why Was This Recalled?
Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains 16mm knee prosthesis and 16mm knee prosthesis packaging contains 12 mm knee prosthesis.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Encore Medical, LP
Encore Medical, LP has 54 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report