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U.S. Department of Health and Human Services

Class 2 Device Recall NextGen Knee

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  Class 2 Device Recall NextGen Knee see related information
Date Initiated by Firm January 27, 2010
Date Posted March 02, 2010
Recall Status1 Terminated 3 on October 17, 2010
Recall Number Z-0915-2010
Recall Event ID 54359
510(K)Number k060370  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product NextGen Knee Gender Solutions CR-Flex Femoral Component, Precoat , Size D, Left. 00-5750-014-01 Zimmer, Inc. Warsaw, IN.
Code Information lot 61369812.
Recalling Firm/
Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact Dale Miller
Manufacturer Reason
for Recall
The package should contain the left knee component but actually contains the right knee component. Delay in completing surgery may result, and a new or different implant may need to be identified.
FDA Determined
Cause 2
Labeling mix-ups
Action The firm sent an immediate notification by e-mail to all first consignees on 1/12/2010. They sent a formal recall notification on 1/27/2010. Customers should contact their Zimmer Sales representative with additional questions.
Quantity in Commerce 14 units
Distribution US and Korea.
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.