Recall Z-1793-2012— Aesculap Implant Systems

Name: FDA recall Z-1793-2012
Creator: U.S. Food and Drug Administration
Published: 2012-02-21

Class II · Terminated

Class II FDA medical device recall by Aesculap Implant Systems, initiated 2012-02-21, terminated 2014-01-15. It names one FDA 510(k) clearance: K083772. 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. 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..

Recalling firm: Aesculap Implant Systems
Classification: Class II
Status: Terminated
Initiated: 2012-02-21
Terminated: 2014-01-15
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K083772 — COLUMBUS REVISION KNEE SYSTEMAesculap Implant System, Inc.·cleared 2009-06-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.