Class 2 Device Recall NexGen Complete Knee Solution MIS Total Knee Procedure Stemmed Tibial Component, Precoat

• Date Initiated by Firm: May 19, 2014
• Date Posted: June 27, 2014
• Recall Status: Terminated on October 29, 2015
• Recall Number: Z-1931-2014
• Recall Event ID: 68457
• 510(K)Number: K043101
• Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
• Product: NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 1. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
• Code Information: Size 1, includes the following Lot numbers: 37217848 61424993 61507222 61543969 61774117 62141262 62193298 62251564 62261955 62383353 62602809 62602810 62602811
• Recalling Firm/ Manufacturer: Zimmer, Inc.; 1800 W Center St; Warsaw IN 46580-2304
• For Additional Information Contact: 800-447-5633
• Manufacturer Reason for Recall: Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
• FDA Determined Cause: Equipment maintenance
• Action: Zimmer sent an Urgent Medical Device Recall letter June 2014 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the notification and ensure affected personnel are aware of the contents. Locate and quarantine any affected product and notify their Zimmer sales representative. Their Zimmer sales representative will remove the recalled product from their facility. For patients that previously had this product implanted, it is recommended that they continue their normal operative follow up routine. Customers with questions were instructed to call 1-877-946-2761.
• Quantity in Commerce: 41,180 total
• Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, 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.

• 510(K) Database: 510(K)s with Product Code = JWH