• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Recall
Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5F7
see related information
Date Posted December 13, 2013
Recall Status1 Open
Recall Number Z-0492-2014
Recall Event ID 66536
Premarket Notification
510(K) Numbers
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, Pennsylvania 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
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = AESCULAP IMPLANT SYSTEM, INC.
-
-