FDA Device recall Z-1482-2020
COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, various sizes, model nos
- FDA Device
- Class II
- terminated
- Published 2020-03-25
On 2020-03-25 the FDA classified a Class II recall of COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, various sizes, 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-1482-2020 |
| 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 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.
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. |
|---|
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-1482-2020%22
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