Class 2 Device Recall Gentle Threads

• Date Initiated by Firm: March 28, 2018
• Create Date: May 08, 2018
• Recall Status: Terminated on March 29, 2019
• Recall Number: Z-1736-2018
• Recall Event ID: 79682
• 510(K)Number: K041274
• Product Classification: soft tissue fixation screw - Product Code HWC
• Product: Gentle Threads, Interference Screw; Model No. 905605, for soft tissue reattachment procedures in the ankle/foot and knee.
• Code Information: lot 326900
• Recalling Firm/ Manufacturer: Zimmer Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582-6989
• For Additional Information Contact: 411 Technical Services; 574-371-3071
• Manufacturer Reason for Recall: Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
• FDA Determined Cause: Nonconforming Material/Component
• Action: The recalling firm issued letters to Distributors as well as to affected Risk Managers and Surgeons. Distributors were instructed to ensure affected team members are aware of the contents of the recall notification, locate and quarantine affected product in inventory, return all affected product from distributorship and from affected hospitals, and submit a list of any additional customer accounts that were not notified of the recall to the recalling firm. Risk Managers were instructed to ensure affected personnel are aware of the contents of the recall notification, quarantine all affected product, and complete the included Certificate of Acknowledgement and return to the recalling firm, even if no affected products were present at the facility. Surgeons were instructed to review the notification and return the completed Certificate of Acknowledgement. Customers' questions and concerns were directed to the recalling firm's customer service at 574-371-3071, 8AM-5PM EST, Monday through Friday. Alternatively, questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.
• Quantity in Commerce: 53
• Distribution: Worldwide distribution. US nationwide, Netherlands, Mexico, Paraguay, Brazil, Argentina, Malaysia, Costa Rica, Chile, South Korea, and Canada.
• 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 = HWC and Original Applicant = ARTHROTEK, INC.