Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

3DKnee e+ Tibial Insert. The insert is used along with Recalled by Encore Medical, Lp Due to U.S. Agent contacted Director Commercial Logistics, notifying him...

Date: April 1, 2013
Company: Encore Medical, Lp
Status: Terminated
Source: FDA (Device)

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. The insert is used along with the other components that comprise the 3DKnee System.

Quantity: 5

Why Was This Recalled?

U.S. Agent contacted Director Commercial Logistics, notifying him of incorrect color coded labels on two packages of e+tibial inserts. There were 8 e+ tibial inserts of the same lot number in Finished Goods as the two from the agency. These devices were inspected and all were incorrectly labeled.

Where Was This Sold?

US Distribution to the state of California and International Distribution to the country of Venezuela.

About Encore Medical, Lp

Encore Medical, Lp has 43 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report