medical Class II Updated 2020-03-25

Aesculap Implant Systems LLC recalls AS COLUMBUS CR/PS TIB.PLAT.CEMENTED,Knee implant components,

Recalled Product

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.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All product with old packaging configuration. New packaging configuration begins with Lot 52533610.
View official government recall

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