Recall Z-1793-2012 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Aesculap Implant Systems
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 cor
| Date | Feb 21, 2012 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| 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. |
| Quantity | 8 |
| Distribution | Nationwide Distribution including PA and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083772 | COLUMBUS REVISION KNEE SYSTEM Aesculap Implant System, Inc., Jun 4, 2009 |