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U.S. Department of Health and Human Services

Class 2 Device Recall NexGen

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  Class 2 Device Recall NexGen see related information
Date Initiated by Firm August 03, 2004
Date Posted September 14, 2004
Recall Status1 Terminated 3 on September 13, 2004
Recall Number Z-1448-04
Recall Event ID 29832
510(K)Number K013385  
Product Classification Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer - Product Code KRO
Product Zimmer brand NEXGEN Complete Knee Solution Rotating Hinge Knee Tibial Component, precoat, nonmodular, size 3, sterile, for cemented use only; Cat. No. 5880-03-02.
Code Information lot 60004557; Exp. December 2008.
Recalling Firm/
Manufacturer
Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
800-846-4637
Manufacturer Reason
for Recall
The polyethylene tibial bushing was omitted from the taper of the tibial plates.
FDA Determined
Cause 2
Other
Action Consignees were notified via recall letter dated August 3, 2004 and sent via certified mail, return receipt requested. A dear doctor letter dated August 25, 2004 was sent to the implanting physicians.
Distribution Nationwide (California, Florida, Illinois, Indiana, Louisiana, Michigan, Nevada, New Jersey, New York, North Carolina, Ohio, Texas, Wisconsin), and Germany.
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 = KRO and Original Applicant = ZIMMER, INC.
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