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
FDA Recall Z-1793-2012 · Posted None
Recalling FirmAesculap Implant Systems
Recall StatusTerminated
Product CodeJWH
Date Initiated2012-02-21
Date Terminated2014-01-15
Product Quantity8
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.
Firm Action
Aesculap Implant Systems (AIS) initiated their recall of this product by first telephoning consignees and then on February 21, 2012 by sending an IMPORTANT RECALL NOTIFICATION letter dated February 21, 2012 to all consignees. The letter identified the affected product, problem and actions to be taken. The notification told consignees not to use the affected product and to return any stock to AIS (USA) promptly. For questions contact Scott Stephan at (610) 984-9239 or Christian Gabriel at (610) 984-9300.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide Distribution including PA and TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.