Columbus Tibia Plateau — Class II medical device recall Z-1793-2012
Terminated recall by Aesculap Implant Systems, reported 2012-06-20, distributed nationwide. During an internal quality inspection, the tibia plateau was found to be out of specification. There is a pote
| Recall number | Z-1793-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aesculap Implant Systems, Center Valley, PA, United States |
| Recall initiated | 2012-02-21 |
| Classified | 2012-06-09 |
| Reported by FDA | 2012-06-20 |
| Terminated | 2014-01-15 |
| Distributed | Nationwide (US) |
| Quantity | 8 |
| Reason classes | specification failure |
Product
Columbus Tibia Plateau (component of the Columbus REVISION Knee System) Product Usage - The Columbus Revision Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplastics or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture
Reason for recall
During an internal quality inspection, the tibia plateau was found to be out of specification. There is a potential for misalignment between the tibia plateau and attachment of the extension stem.
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-1793-2012. 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.