Class 2 Device Recall NexGen Complete Knee Solution Rotating Hinge Knee tibial broach impactor

• Date Initiated by Firm: April 16, 2010
• Date Posted: December 13, 2010
• Recall Status: Terminated on September 12, 2012
• Recall Number: Z-0610-2011
• Recall Event ID: 55363
• Product Classification: Orthopedic manual surgical instrument - Product Code LXH
• Product: NexGen Complete Knee Solution Rotating Hinge Knee tibial broach impactor, Catalog # 00-5881-080-00, Zimmer Inc., Warsaw, IN.
• Code Information: 77706800, 79006000, 50088600, 51580800, 52153800, 60009328, 60040337, 60050566, 60067099, 60139584, 60195841, 60236368, 60266687, 60297665, 60537409, 60633099, 60777631, 60856861 and 60931933.
• Recalling Firm/ Manufacturer: Zimmer Inc.; 345 E Main St; Warsaw IN 46580-2746
• For Additional Information Contact: 574-372-4807
• Manufacturer Reason for Recall: The impactor may disassemble or detach during use. The detached piece may not be observed intraoperatively and may be left in the surgical site. Complications may include pain, infection, and prolongation in surgery. These complications may also require revision surgery.
• FDA Determined Cause: Device Design
• Action: Zimmer issued "Urgent Medical Device Safety Alert" letters dated April 16, 2010 to Risk Managers, user facilities, Health Care Professionals and Zimmer Sales force. The users were informed to inspect the device for loosening. The alert also informed users to inspect the device after each use to verify that the device was intact. Customers were instructed to complete and return a User Facility Documentation Form. Zimmer will repair and replace all affected devices. Customers can contact ZImmer, Inc. at 800 613-6131 concerning this recall.
• Quantity in Commerce: 10,666 both products
• Distribution: Worldwide Distribution: Throughout US including Puerto Rico, and the countries of Argentina, Australia, Belgium, Bolivia, Brazil, Canada, Chile, China, Columbia, Denmark, Ecuador, El Salvador, France, Germany, Guatemala, Hong Kong, India, Italy, Japan, Korea, Mexico, Netherlands, Nicaragua, Panama, Peru, Portugal, Singapore, Spain, Switzerland, Taiwan, Thailand, Turkey, Ukraine, and United Kingdom.
• 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.