Recall Z-1480-2020— Aesculap Implant Systems LLC

Name: FDA recall Z-1480-2020
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: K053390. Product: COLUMBUS CRA/PSA TIB.PLAT.CEMENTED, Knee implant components, various sizes, model nos. NN469K NN470K NN471K NN472K NN473K NN474K NN475K NN476K NN477K NN478K NN479K 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

K053390 — COLUMBUS (CR) TOTAL KNEE SYSTEMAesculap, Inc.·cleared 2006-02-06

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 CRA/PSA TIB.PLAT.CEMENTED, Knee implant components, various sizes, model nos. NN469K NN470K NN471K NN472K NN473K NN474K NN475K NN476K NN477K NN478K NN479K 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.