Aesculap Implant Systems Recalls
Showing 1-3 of 3 recalls
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.
Quintex Cervical Plating System - Screws. The Quintex Cervical Plating System is intended for the treatment of cervical spinal instability. The Quintex Cervical Screws are available in three different versions: semi-constrained, constrained, and dynamic. The screws all have a head diameter of 4.0mm and vary in length from 10mm to 22mm. Rescue screws are also available with a 4.5mm head diameter and lengths of 11-19mm.
The firm has received complaints that the locking ring that sits in the head of the screw can come out of the screw head when engaged with the screwdriver if the screwdriver is improperly angled.
The firm initiated this recall by sending an "Important Recall Notification" letter to consignees on January 20, 2012. This letter instructed consignees not to use the product and requested that all stock be returned to the recalling firm promptly. Customers may contact 1-(866) 229-3002 for questions.
Excia Cemented Hip Stems, Size 9mm, Part Number: NJ309K, Aesculap Implant Systems, Inc., Center Valley, PA 18034
Sterility (package integrity) Compromised: Device package damaged during shipment
The recalling firm issued an Important Recall Notice letter dated 10/10/07 to all their customers informing them of the problem and the need to return the product.