Class 2 Device Recall NextGen Knee

• Date Initiated by Firm: January 27, 2010
• Date Posted: March 02, 2010
• Recall Status: Terminated on October 17, 2010
• Recall Number: Z-0915-2010
• Recall Event ID: 54359
• 510(K)Number: K060370
• Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
• Product: NextGen Knee Gender Solutions CR-Flex Femoral Component, Precoat , Size D, Left. 00-5750-014-01 Zimmer, Inc. Warsaw, IN.
• Code Information: lot 61369812.
• Recalling Firm/ Manufacturer: Zimmer Inc.; 345 E Main St; Warsaw IN 46580-2746
• For Additional Information Contact: Dale Miller; 574-267-6131
• Manufacturer Reason for Recall: The package should contain the left knee component but actually contains the right knee component. Delay in completing surgery may result, and a new or different implant may need to be identified.
• FDA Determined Cause: Labeling mix-ups
• Action: The firm sent an immediate notification by e-mail to all first consignees on 1/12/2010. They sent a formal recall notification on 1/27/2010. Customers should contact their Zimmer Sales representative with additional questions.
• Quantity in Commerce: 14 units
• Distribution: US and Korea.
• 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