Recall Z-1478-2020— Aesculap Implant Systems LLC

Name: FDA recall Z-1478-2020
Creator: U.S. Food and Drug Administration
Published: 2020-01-21

Class II · Terminated

Class II FDA medical device recall by Aesculap Implant Systems LLC, initiated 2020-01-21, terminated 2021-09-22. It names one FDA 510(k) clearance: K022672. 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.. Reason: Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging..

Recalling firm: Aesculap Implant Systems LLC
Classification: Class II
Status: Terminated
Initiated: 2020-01-21
Terminated: 2021-09-22
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K022672 — COLUMBUS TOTAL KNEE SYSTEM (CR)Aesculap, Inc.·cleared 2002-11-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.