Aesculap, Inc. recalls Columbus Revision Knee System, EnduRo Knee System Product Usage: The Columbus Revision Knee System and EnduRo Knee Syst…

Recall date

November 30, 2015

Source

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

Recall number

Z-1043-2016

FDA classification

Class II

Brand / firm

Aesculap, Inc.

Sold / distributed

US Nationwide Distribution

Why it was recalled

Aesculap Inc. US has initiated a recall on Tibial and Femur extension sterile pressfit stem implant packaging that are used for Columbus Revision/Enduro Knee Implants because it is labeled as Cementless. US product is indicated in the US for use with Bone Cement only.

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

What was recalled

Columbus Revision Knee System, EnduRo Knee System Product Usage: The Columbus Revision Knee System and EnduRo Knee System are indicated for use in reconstruction of the diseased knee joint.