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U.S. Department of Health and Human Services

Class 2 Device Recall NexGen Complete Knee Solution MIS Total Knee Procedure Stemmed Tibial Component, Precoat

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 Class 2 Device Recall NexGen Complete Knee Solution MIS Total Knee Procedure Stemmed Tibial Component, Precoatsee related information
Date Initiated by FirmMay 19, 2014
Date PostedJune 27, 2014
Recall Status1 Terminated 3 on October 29, 2015
Recall NumberZ-1938-2014
Recall Event ID 68457
510(K)NumberK043101 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductNexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 7. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
Code Information Size 7, includes the following Lot Numbers: 370320 37214653 61424998 61442326 61459971 61459972 61488229 61518205 61543979 61658887 61658888 61827120 61827121 61827122 61979040 61979041 62051526 62091729 62200288 62227423 62251572 62330688 62383359 62383362 62401016 62401017 62602812 62602813 62640983 
Recalling Firm/
Manufacturer		 Zimmer, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact
800-447-5633
Manufacturer Reason
for Recall		Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
FDA Determined
Cause 2		Equipment maintenance
ActionZimmer sent an Urgent Medical Device Recall letter June 2014 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the notification and ensure affected personnel are aware of the contents. Locate and quarantine any affected product and notify their Zimmer sales representative. Their Zimmer sales representative will remove the recalled product from their facility. For patients that previously had this product implanted, it is recommended that they continue their normal operative follow up routine. Customers with questions were instructed to call 1-877-946-2761.
Quantity in Commerce41,180 total
DistributionWorldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JWH
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