Aesculap Implant Systems LLC recalls AS COLUMBUS CR/PS TIB.PLAT.CEMENTED,Knee implant components, various sizes, model nos. NN058Z NN070Z NN071Z NN072Z NN07…

Recall date

January 21, 2020

Source

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

Recall number

Z-1481-2020

FDA classification

Class II

Brand / firm

Aesculap Implant Systems LLC

Sold / distributed

Worldwide distribution - US Nationwide distribution in the states of AL, CA, CO, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, OH, OK, OR, PA, TN, TX, UT, WA and countries of Saudi Arabia, Utd. Arab Emir., Argentina, Austria, Australia, Bosnia-Herz., Bulgaria, Brazil, Switzerland, Chile, Chin…

Why it was recalled

Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.

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

What was recalled

AS COLUMBUS CR/PS TIB.PLAT.CEMENTED,Knee implant components, various sizes, model nos. NN058Z NN070Z NN071Z NN072Z NN073Z NN074Z NN075Z NN076Z NN077Z NN078Z NN079Z NN470Z NN471Z NN472Z NN473Z NN474Z NN475Z NN476Z NN477Z NN478Z NN479Z Product Usage: Tibia-Plateaus are part of implants in the group of knee endoprosthetics. For these implant parts there are cemented and cement-free versions as well as versions with zirconium nitride multi layer.