FDA Device recall Z-1043-2016
Columbus Revision Knee System, EnduRo Knee System Product Usage: The Columbus Revision Knee System and EnduRo Knee System are indicated for…
- FDA Device
- Class II
- terminated
- Published 2016-03-09
On 2016-03-09 the FDA classified a Class II recall of Columbus Revision Knee System, EnduRo Knee System Product Usage: The Columbus Revision Knee System and EnduRo Knee System are indicated for… by Aesculap, citing aesculap Inc. US has initiated a recall on Tibial and Femur extension sterile pressfit stem implant packaging that are used for Columbus Revision/Enduro Knee Implants because it i….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1043-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-30 |
| Published | 2016-03-09 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Aesculap |
| Distribution | US |
Product
Columbus Revision Knee System, EnduRo Knee System Product Usage: The Columbus Revision Knee System and EnduRo Knee System are indicated for use in reconstruction of the diseased knee joint.
Reason
Aesculap Inc. US has initiated a recall on Tibial and Femur extension sterile pressfit stem implant packaging that are used for Columbus Revision/Enduro Knee Implants because it is labeled as Cementless. US product is indicated in the US for use with Bone Cement only.
Identifiers
| code_info | All codes |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1043-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.