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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, Precoat see related information
Date Initiated by Firm May 19, 2014
Date Posted June 27, 2014
Recall Status1 Terminated 3 on October 29, 2015
Recall Number Z-1937-2014
Recall Event ID 68457
510(K)Number K043101  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 6. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
Code Information Size 6, includes the following Lot Numbers: 370319 37213647 37218135 37218727 37219556 37220950 61414605 61414606 61442322 61451224 61451225 61451226 61479488 61479489 61479490 61518197 61518198 61518199 61538053 61543978 61592093 61592094 61627261 61643938 61672569 61682157 61685470 61721675 61721676 61774189 61774190 61774191 61774195 61863158 61863159 61863160 61863161 61863162 61979034 61979035 62016163 62022560 62037896 62041306 62041308 62069549 62077856 62141261 62143609 62168186 62177113 62227421 62227422 62251569 62251570 62261977 62261978 62326316 62330687 62341281 62369796 62369797 62377652 62473295 62473296 62602804 62602805 62602806 62602807 62602808 
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
Action Zimmer 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 Commerce 41,180 total
Distribution Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.
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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