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
Recall
- Recall Number
- Z-1793-2012
- Event Number
- 61332
- Firm
- Aesculap Implant Systems
- FEI Number
- 2916714
- Product Code
- JWH
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- February 21, 2012
- Terminated
- January 15, 2014
- Address
- 3773 Corporate Pkwy, Center Valley, PA, 18034-8217
Description
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
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.
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.
Nationwide Distribution including PA and TX.
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