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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Nexgen Complete Knee Solution Minimally Invasive Solutions Procedures Trabecular Metal Techno

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 Class 2 Recall
Zimmer Nexgen Complete Knee Solution Minimally Invasive Solutions Procedures Trabecular Metal Techno
see related information
Date Posted March 10, 2010
Recall Status1 Terminated on March 23, 2011
Recall Number Z-1064-2010
Recall Event ID 53942
Premarket Notification
510(K) Number
K072160 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product Zimmer NexGen Complete Knee Solution Minimally Invasive Solutions Procedures Trabecular Metal Technology Tibial Tray, fixed bearing, size 8, sterile, Zimmer, Warsaw, Indiana; REF 00-5954-057-02. The product is used as an implant for knee replacement.
Code Information All lots. Lots 00111134, 60747593, 60747594, 60752676, 60752677, 60760248, 60768076, 60821507, 60824004, 60830411, 60830412, 60845351, 60850604, 60852670, 60852671, 60860895, 60866613, 60872311, 60879050, 60892605, 60900745, 60907449, 60917234, 60922494, 60938889, 60938890, 60947027, 60947028, 60963035, 60963036, 60963037, 60963039, 60983254, 61015851, 61028168, 61033723, 61033724, 61068387, 61068388, 61068389, 61074754, 61074755, 61084771, 61096604, 61116246, 61116247, 61137056, 61143427, 61149041, 61157940, 61173295, 61193516, 61193520, 61198179, 61204038, 61215644, 61225562, 61235612, 61240323, 61248321, 61259184, 61263170, 61272449, 61285508, 61298201, 61306497, 61280371, 61315873, 61319581 and 61329266.
Recalling Firm/
Manufacturer
Zimmer Inc.
345 E Main St
Warsaw, Indiana 46580-2746
Manufacturer Reason
for Recall
The titanium portion of the implant may separate from the trabecular metal material.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action On December 1, 2009, an e-mail was sent to consignees for lot 60866613 to quarantine and return the product. On December 2, 2009 an e-mail was sent to U.S. distributors, and on December 3, 2009 and e-mail was sent to international distributors, instructing them to suspend usage and return all lots of size 8 trays. On December 9, 2009, a recall letter was sent to U.S. user accounts who received the products directly from Zimmer, U.S. distributors and Zimmer's U.S. sales force informing them of the recall. Direct questions about this recall to Zimmer, Inc. by calling 1-800-613-6131.
Quantity in Commerce 846
Distribution Worldwide Distribution -- United States, Australia, Austria, Belgium, Canada, Denmark, France, Germany, Italy, Saudi Arabia, Spain, Sweden, Switzerland and the United Kingdom.
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 = ZIMMER, INC.
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