Class II — Potential Health Hazard

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

Foundation Modular Femoral Stem Recalled by Encore Medical, Lp Due to After receipt of a product complaint for the...

Date: May 14, 2018
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

Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis component. The Foundation Revision Knee is a total knee system indicated as knee joint replacement for patients suffering from pain and dysfunction.

Quantity: 12

Why Was This Recalled?

After receipt of a product complaint for the labeling, it was determined that this device does not have FDA clearance.

Where Was This Sold?

This product was distributed to 6 states: AZ, MS, MO, NY, OK, UT

Affected (6 states)Not affected

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