Class 2 Device Recall Acetabular Hip Replacement Components

• Date Initiated by Firm: August 25, 2017
• Create Date: February 15, 2018
• Recall Status: Terminated on August 16, 2018
• Recall Number: Z-0626-2018
• Recall Event ID: 79104
• 510(K)Number: K150552
• Product Classification: Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented - Product Code KWY
• Product: G7 DUAL MOBILITY LINER 44MM F Product Usage: Intended for use in hip arthroplasty cases which involves the removal of the damaged joint and tissues to be replaced with artificial prosthesis. The result of the procedure is to relieve pain and restore a sense of normal function and mobility to the damaged joint.
• Code Information: Item #110024464 Lot# 478340
• Recalling Firm/ Manufacturer: Zimmer Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582-6989
• For Additional Information Contact: 411 Technical Services; 574-372-3071
• Manufacturer Reason for Recall: The affected products are labeled and etched as F-44 mm liners; however, the physical products could potentially be E-42 mm liners.
• FDA Determined Cause: Mixed-up of materials/components
• Action: On August 30, 2017 an Urgent medical device recall removal notice was mailed to customers identified as "G7 Dual Mobility Liner". The recall letter requests the following actions to be taken: 1. Review this notification and ensure affected team members are aware of the contents. CF04107 Rev. 2, Eff. Date: 21 Feb. 2017 Ref. CP04102 Recall Activities Page 2 of 4 ZFA 2017-347 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1  Inventory Return Certification Form. a. Return a digital copy to corporate quality.postmarket@zimmerbiomet.com within three (3) days. 4. Immediately return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1  Inventory Return Certification Form to Zimmer Biomet. Questions or concerns can be directed to Customer Service at 1-574-371-3071
• Quantity in Commerce: 8
• Distribution: US Nationwide Distribution
• 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 = KWY