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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Gender Solutions Natural Knee Flex System, Gender Solutions Male, Femoral Component

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  Class 2 Device Recall Zimmer Gender Solutions Natural Knee Flex System, Gender Solutions Male, Femoral Component see related information
Date Initiated by Firm April 29, 2009
Date Posted June 26, 2009
Recall Status1 Terminated 3 on October 21, 2009
Recall Number Z-1477-2009
Recall Event ID 52004
510(K)Number K070214  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Zimmer Gender Solutions Natural Knee Flex System, Gender Solutions Male, Femoral Component, nonporous, size 4, left, sterile, Zimmer, Warsaw, IN; Product Number: 00-5410-017-01.

Knee implant used to replace the distal surface of the human femur in total knee arthroplasty surgery. For use in Non-inflammatory Degenerative Joint Disease or Inflammatory Joint Disease, deformity, moderate contracture or failed previous surgery. Product is indicated for uncemented or cemented use.
Code Information Lot Number: 60998487.
Recalling Firm/
Manufacturer		 Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
800-613-6131
Manufacturer Reason
for Recall		 The tyvek lid, which is intended to assure sterility until the device is transported to the operating room, may be missing from the inner tray.
FDA Determined
Cause 2		 Employee error
Action Zimmer, Inc. issued an "Urgent: Device Recall" letter dated April 29, 2009 informing all consignees of the affected product. Users were instructed to locate and quarantine all unused devices and ship them to the firm with a completed Inventory Return Certification form. Return Certification forms are also to be sent via fax to Zimmer, Inc. at 1-574-372-4265. For further questions, contact Zimmer, Inc. at 1-800-613-6131.
Quantity in Commerce 14
Distribution Worldwide Distribution -- US including states of FL, MN, MS, NY, OH, TN, TX and WI and Switzerland.
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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