Zimmer, Inc. recalls Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185. packaged in configuration 803/791. Knee Prosthesis comp…

Recall date

October 2, 2014

Source

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

Recall number

Z-1948-2015

FDA classification

Class II

Brand / firm

Zimmer, Inc.

Sold / distributed

US Nationwide Distribution, including DC and the states of AL, AZ, CA, CO, FL, GA, IL, IN, KS, LA, MD, MI, MN, MO, MT, NC, ND, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, and WY.

Why it was recalled

Failed to meet established requirements for sterile barrier integrity due to a breach of the inner cavity. If the outer tray is compromised in addition to the inner tray a periprosthetic infection may occur. The risk associated with a periprosthetic infection is a revision or potential multi-stage revision to treat the infection.

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

What was recalled

Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185. packaged in configuration 803/791. Knee Prosthesis component.