Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
3DKnee e+ Tibial Insert - HXLPE-VE Recalled by Encore Medical, Lp Due to The firm is recalling one lot of 392-09-706,...
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
3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, Sz 2/9mm. The insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along lateral condyle. This insert is to be used along with the other components that comprise the 3DKnee System.
Quantity: 7 units
Why Was This Recalled?
The firm is recalling one lot of 392-09-706, 3DKnee e+ Tibial insert, 9 mm, Size 6, Right. The shelf life labeling of specific lots for a component were found to be incorrect and were found to be expired.
Where Was This Sold?
Worldwide Distribution including Venezuela.
About Encore Medical, Lp
Encore Medical, Lp has 43 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report