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Aesculap Implant Systems LLC recalls Columbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant components, model nos. NN058K NN070K NN071K NN072K N
Recalled March 25, 2020 · FDA recall Z-1478-2020 · Aesculap Implant Systems
Hazard
Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging. · FDA Class II
Units
24010
Sold at
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, China, Colombia, Costa Rica, Cuba, Czech Republic, Germany, Algeria, Ecuador, Estonia, Spain, United Kingdom, Georgia, Greece, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Iraq, Iran, Italy, Jordan, Japan, South Korea, Lithuania, Latvia, Libya, Moldavia, Mexico, Malaysia, Nigeria, Netherlands, Poland, Portugal, Paraguay, Russian Fed., Singapore, El Salvador, Thailand, Turkey, Ukraine, South Africa.
Description
Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.
Product
Columbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant components, model nos. NN058K NN070K NN071K NN072K NN073K NN074K NN075K NN076K NN077K NN078K NN079K 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.
Manufacturer(s)
Aesculap Implant Systems LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →