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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-1936-2014
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 5. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
Code Information Size 5, includes the following Lot numbers: 370318 37214652 61424997 61442318 61442319 61442320 61451223 61454955 61454956 61459968 61459969 61459970 61475130 61475131 61475132 61488234 61518182 61518183 61518184 61526402 61543977 61567344 61567345 61592091 61592092 61627258 61627260 61643935 61643936 61658884 61658885 61658886 61774178 61774179 61774180 61774181 61774182 61774183 61863148 61863149 61863150 61863151 61863152 61912439 61934688 61934689 61935101 61935102 61979031 61979032 61979033 62016160 62016162 62022559 62037894 62037895 62051524 62051525 62069546 62089014 62089015 62143608 62168185 62177112 62193308 62200281 62200282 62200283 62214674 62214675 62227420 62261968 62261972 62261973 62261975 62298570 62332566 62352641 62358491 62358492 62377651 62423843 62455679 62460240 62460242 62460243 62525441 62525442 62586581 62586582 62610910 62610911 62610912 62640982 62646149 62646150 
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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