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Aesculap Implant Systems recalls Columbus Tibia Plateau (component of the Columbus REVISION Knee System) Product Usage - The Columbus Revision Knee Sy
Recalled June 20, 2012 · FDA recall Z-1793-2012 · Aesculap Implant Systems
Hazard
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. · FDA Class II
Units
8
Sold at
Nationwide Distribution including PA and TX.
Description
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.
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
Manufacturer(s)
Aesculap Implant Systems
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →