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

• Date Initiated by Firm: October 08, 2009
• Date Posted: November 13, 2009
• Recall Status: Terminated on May 16, 2011
• Recall Number: Z-0243-2010
• 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, 19 MM height, for use with baseplate size 3, 4 or 5, sterile, Zimmer, Warsaw, IN; REF 00-5428-013-19. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals.
• Code Information: Lots 60975063, 60975064, 60980774, 60980775, 60980776, 60993022, 60993023, 60993024, 61023695, 61027941, 61036384, 61036413, 61051493, 61058634, 61065064, 61075266, 61078776, 61096389, 61096390, 61106582 and 61114203.
• 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: 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