FDA Device recall Z-1478-2020
Columbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant components, model nos
- FDA Device
- Class II
- terminated
- Published 2020-03-25
On 2020-03-25 the FDA classified a Class II recall of Columbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant components, model nos by Aesculap Implant Systems, citing low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1478-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-01-21 |
| Published | 2020-03-25 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Aesculap Implant Systems |
| Distribution | US |
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.
Identifiers
| code_info | All product with old packaging configuration. New packaging configuration begins with Lot 52533610. Lots recalled:…All product with old packaging configuration. New packaging configuration begins with Lot 52533610. Lots recalled: 51304393 51305032 51308465 51308467 51308475 51308477 51309717 51309718 51309719 51309720 51309721 51309722 51309724 51309725 51309726 51309727 51309728 51309751 51309752 51309753 51309757 51309771 51309772 51311075 51311078 51311083 51312411 51312419 51312426 51312436 51313562 51313563 51313564 51313565 51313566 51313569 51313570 51313797 51314080 51314081 51316258 51316259 51316260 51316281 51316282 51316283 51316288 51316292 51316302 51317871 51317872 51317879 51317882 51317883 51319365 51319376 51319377 51320769 51322218 51322219 51322220 51322241 51322242 51322680 51322708 51323350 51323353 51323354 51323355 51323401 51323402 51324438 51324732 51324733 51324734 51324735 51324736 51324737 51324804 51324805 51324816 51324818 51324820 51324821 51324822 51325086 51325087 51325088 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1478-2020%22
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