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U.S. Department of Health and Human Services

Class 2 Device Recall Nexgen Complete Knee System

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  Class 2 Device Recall Nexgen Complete Knee System see related information
Date Initiated by Firm February 24, 2012
Date Posted May 14, 2012
Recall Status1 Terminated 3 on April 18, 2014
Recall Number Z-1580-2012
Recall Event ID 61468
510(K)Number K003910  K933785  K892800  K951185  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product 00-5952-31-12, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Yellow A-E Micro 12mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN

The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.
Code Information Part 00-595203112, all lots
Recalling Firm/
Manufacturer
Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
574-372-4807
Manufacturer Reason
for Recall
Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
FDA Determined
Cause 2
Labeling design
Action Zimmer sent an Urgent Correction Notice dated March 5, 2012, to all affected customers via telephone, E-mail and letter notifying users of the appropriate compatibility of micro sizes of NexGen¿ CR and CR-Flex Articular Surfaces and informing them of known cases of incompatible devices being implanted, including associated risks. Customers and surgeons were asked to acknowledge receipt by calling 1-888-912-7349. Questions and concerns or help in notiying accounts about this correction were to be addressed to 1-888-548-8514. For questions regarding this recall call 574-372-4807.
Quantity in Commerce 83,322 all sizes
Distribution Worldwide Distribution - USA (nationwide) and the countries of Poland, Taiwan, Denmark, Korea, Singapore, China, Canada, Australia, Japan, France, Italy, UK, Germany, Spain, Belgium, Portugal, Switzerland, Sweden, India, Thailand, Peru, The Netherlands, Malaysia, and Austria.
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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