Class 2 Device Recall Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5F7

• Date Initiated by Firm: September 19, 2013
• Date Posted: December 13, 2013
• Recall Status: Terminated on December 22, 2014
• Recall Number: Z-0492-2014
• Recall Event ID: 66536
• 510(K)Number: K083772 K122985
• Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
• Product: Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7
• Code Information: lots: 51468773, 51447588, 51468302, 51503760, 51571394, 51585136, 51447597
• Recalling Firm/ Manufacturer: Aesculap, Inc.; 3773 Corporate Pkwy; Center Valley PA 18034-8217
• For Additional Information Contact: Customer Support; 800-258-1946 Ext. 5067
• Manufacturer Reason for Recall: The Columbus Revision CoCr 15 mm distal and posterior implant spacers, sizes F5-F7, were not compatible.
• FDA Determined Cause: Component change control
• Action: Domestic consignees were contacted by phone and a recall notification letters was also sent to these Users on/about September 26, 2013.
• Quantity in Commerce: 24
• Distribution: Distributed in FL and MD.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JWH