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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Gender Solutions Natural Knee Flex System, Prolong Articular Surface,

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  Class 2 Device Recall Zimmer Gender Solutions Natural Knee Flex System, Prolong Articular Surface, see related information
Date Initiated by Firm October 08, 2009
Date Posted November 13, 2009
Recall Status1 Terminated 3 on May 16, 2011
Recall Number Z-0242-2010
Recall Event ID 53399
510(K)Number K070214  
Product Classification Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/ - Product Code JWH
Product Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, left, 16 MM height, for use with baseplate size 3, 4 or 5, sterile, Zimmer, Warsaw, IN; REF 00-5428-013-16.

The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals.
Code Information Lots 60943133, 60943134, 60975062, 60981875, 60987845, 60993018, 60993019, 60993020, 60993021, 61001565, 61023694, 61027938, 61027940, 61036383, 61036412, 61045110, 61051492, 61065063, 61069430, 61078775, 61085895, 61096387, 61096388, 61106581, 61114202 and 60937774.
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 surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
FDA Determined
Cause 2		 Other
Action An "Urgent: Field Correction" dated October 8, 2009 was issued to Consignees. The notification letter described the affected product, issue, health risks and actions for customers to take. The letter notified consignees of a changed to the surgical technique, to include the use of a new peripheral rib impactor tool. Notifications of this field notification were sent to all affected direct accounts of Zimmer, Inc. Contact your Zimmer Sales Representative if you have any questions regarding this action. For shipping assistance, questions or assistance in notifying your accounts about the field correction please contact Zimmer, Inc. at 1-800-613-6131.
Quantity in Commerce 26,404 of all products
Distribution Worldwide Distribution -- United States, Austria, Belgium, France, Germany, Japan, Spain 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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