Class 2 Device Recall Zimmer NEXGEN Complete Knee Solution articular surface insertion instrument

• Date Initiated by Firm: May 16, 2008
• Date Posted: September 11, 2008
• Recall Status: Terminated on November 12, 2009
• Recall Number: Z-1863-2008
• Recall Event ID: 48170
• Product Classification: Orthopedic manual surgical instrument - Product Code LXH
• Product: Zimmer NEXGEN Complete Knee Solution articular surface insertion instrument, non-sterile. This device is a surgical instrument used during knee arthroplasty procedures to snap or lock the polyethylene bearing surface into the retaining rail on a metal tibial plate.
• Code Information: Lots 60577285, 60582624, 60587308, 60603255 and 60610860.
• Recalling Firm/ Manufacturer: Zimmer Inc.; 345 E Main St; Warsaw IN 46580-2746
• For Additional Information Contact: 574-372-4487
• Manufacturer Reason for Recall: The instrument is prone to fracture during use.
• FDA Determined Cause: Process control
• Action: Direct and hospital consignees were notified via email or letter on 5/16/08 to cease use and return the instruments. Contact Kevin W. Escapule at 800-846-4637 if you have questions.
• Quantity in Commerce: 500
• Distribution: Nationwide, Australia, Canada, China, Germany, India, Japan, Korea, Mexico, Singapore, Spain, Sweden and Taiwan.
• 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.