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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5F7 see related information
Date Initiated by Firm September 19, 2013
Date Posted December 13, 2013
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = AESCULAP IMPLANT SYSTEM, INC.
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