Encore Medical, Lp recalls Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis component. The Foundation Revision Knee is a…

Recall date

May 14, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2967-2018

FDA classification

Class II

Brand / firm

Encore Medical, Lp

Sold / distributed

U.S. Distribution to states of: AZ, MO, MS, NY, OK, and UT; internationally to: Japan.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.