medical Class II Updated 2020-03-25

Aesculap Implant Systems LLC recalls COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant component

Recalled Product

COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, various sizes, model nos. NR068K NR068Z NR070K NR070Z NR071K NR071Z NR072K NR072Z NR073K NR073Z NR074K NR074Z NR075K NR075Z NR076K NR076Z NR077K NR077Z NR078K NR078Z NR079K NR079Z 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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