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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-1933-2014
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 3. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
Code Information Size 3, includes the following Lot numbers: 370316 37214039 61414610 61414611 61442294 61442295 61442296 61442297 61450963 61450964 61450965 61454951 61454952 61454953 61459941 61459942 61475123 61475124 61488064 61488065 61488066 61488067 61488068 61497512 61497513 61507223 61507224 61518151 61518153 61518154 61526398 61526399 61558358 61558359 61558360 61558361 61567336 61567337 61567338 61567339 61592084 61592085 61592086 61592087 61627191 61627192 61627193 61627194 61627195 61627196 61627197 61627198 61627199 61627201 61627202 61643928 61643929 61643930 61643931 61643932 61658872 61658873 61658874 61658875 61658876 61658877 61672561 61672562 61672563 61672564 61672565 61672566 61721668 61721669 61721670 61774134 61774135 61774136 61774137 61774140 61774141 61774142 61827112 61827113 61827114 61827115 61827116 61863088 61863090 61863091 61863093 61863094 61898777 61898778 61898779 61898780 61898781 61912437 61914863 61914864 61914865 61934678 61934679 61934680 61934681 61934682 61958855 61958856 61958857 61958858 61979024 61979025 61979026 61979027 61993771 61993773 61993774 61993775 61993776 62022557 62029925 62029926 62029927 62037892 62041300 62041301 62041302 62060611 62060612 62064931 62064932 62064933 62069538 62077846 62077847 62077848 62080358 62080359 62080360 62143198 62143199 62143201 62143601 62143602 62143603 62168181 62168182 62193299 62193301 62193302 62193303 62200277 62200278 62200279 62214665 62214666 62214667 62214668 62214669 62227415 62227416 62227417 62271422 62271423 62271424 62271425 62271426 62284606 62284607 62284608 62298568 62298569 62319299 62326502 62326503 62332546 62332547 62335852 62335864 62345560 62352633 62352634 62357204 62357205 62377654 62377655 62383356 62383357 62389590 62389591 62389592 62423838 62423839 62423840 62454586 62454587 62460233 62460234 62462894 62462895 62465729 62465730 62465731 62473291 62473292 62473294 62525438 62525439 62525440 62528591 62528592 62528593 62528594 62528595 62610905 62610906 62610907 62610908 62610909 62640971 62640972 62640973 62640974 62640975 62646143 62646144 62646145 62649650 62649652 62649653 62649655 
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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