Columbus Revision Knee System — Class II medical device recall Z-1043-2016
Terminated recall by Aesculap, Inc., reported 2016-03-09, distributed nationwide. Aesculap Inc. US has initiated a recall on Tibial and Femur extension sterile pressfit stem implant packaging
| Recall number | Z-1043-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aesculap, Inc., Center Valley, PA, United States |
| Recall initiated | 2015-11-30 |
| Classified | 2016-03-03 |
| Reported by FDA | 2016-03-09 |
| Terminated | 2016-10-13 |
| Distributed | Nationwide (US) |
| Quantity | 1,232 |
| Reason classes | labeling, sterility |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1043-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.