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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 Device Recall Zimmer Nexgen Complete Knee Solution Minimally Invasive Solutions Procedures Trabecular Metal Techno see related information
Date Initiated by Firm November 16, 2009
Date Posted March 10, 2010
Recall Status1 Terminated 3 on March 23, 2011
Recall Number Z-1064-2010
Recall Event ID 53942
510(K)Number K072160  
Product Classification Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/ - 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 IN 46580-2746
For Additional Information Contact
800-613-6131
Manufacturer Reason
for Recall		 The titanium portion of the implant may separate from the trabecular metal material.
FDA Determined
Cause 2		 Other
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 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 = ZIMMER, INC.
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