Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 arthropla — recall Z-1793-2012

U.S. FDA — Device Enforcement · United States · 2012-02-21 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1793-2012
Date of alert: 2012-02-21
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Aesculap Implant Systems
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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