Class 2 Device Recall Zimmer Gender Solutions

• Date Initiated by Firm: September 28, 2016
• Create Date: October 26, 2016
• Recall Status: Terminated on April 16, 2020
• Recall Number: Z-0317-2017
• Recall Event ID: 75371
• Product Classification: Saw, powered, and accessories - Product Code HAB
• Product: Zimmer Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece
• Code Information: Item Number 00-5927-040-00 Serial Number All
• Recalling Firm/ Manufacturer: Zimmer Biomet, Inc.; 1800 W Center St; Warsaw IN 46580-2304
• For Additional Information Contact: Customer Call Center; 877-946-2761
• Manufacturer Reason for Recall: Complaints have been reported that the handpiece is inoperable. The investigation found that the complaints were related to the lack of preventative maintenance contrary to what is recommended in the instructions for use included with the handpiece. An inoperable device may lead to a delay in surgery
• FDA Determined Cause: Labeling design
• Action: On 9/28/2016, URGENT MEDICAL DEVICE FIELD REMOVAL notifications were sent to the affected distributors and Risk Managers / Surgeons via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Risk Managers and Surgeons Risk Manager Responsibilities: 1. Review this notification and ensure affected personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative with quarantining all affected product. 3. Your Zimmer Biomet sales representative will remove the affected product from your facility for the initial preventative maintenance and arrange for a loaner device. It is estimated that your handpieces will undergo preventative maintenance sometime between November 2016 and March 2017. 4. Complete Attachment 3  Certificate of Acknowledgement. a. Return a digital copy via email to CPWARFieldAction@zimmerbiomet.com or via fax to 574-372-1683 within three (3) days. b. Retain a copy of the Acknowledgement Form with your field removal records in the event of a compliance audit of your facilities documentation. 5. If after reviewing this notice you have further questions or concerns please call the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an on-call representative in the case of an emergency. Alternatively, your questions may be sent by email to CPWARFieldAction@zimmerbiomet.com. Surgeon Responsibilities: 1. Review this notification for awareness of the contents. 2. There are no specific patient monitoring instructions related to this field removal that are recommended beyond your existing follow up schedule. 3. Complete Attachment 3  Certificate of Acknowledgement. a. Return a digital copy via email to
• Quantity in Commerce: 703
• Distribution: Nationwide. CANADA HONG KONG KOREA SINGAPORE CHINA VENEZUELA AUSTRALIA JAPAN NETHERLANDS GERMANY INDIA 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.