Class 2 Device Recall COMP 12MM HUM FRAC STEM MACRO

• Date Initiated by Firm: June 05, 2017
• Create Date: December 29, 2017
• Recall Status: Terminated on March 06, 2018
• Recall Number: Z-0298-2018
• Recall Event ID: 78167
• 510(K)Number: K023063
• Product Classification: Prosthesis, shoulder, non-constrained, metal/polymer cemented - Product Code KWT
• Product: COMP 12MM HUM FRAC STEM MACRO, model # 11-113562
• Code Information: Lot Number: 529890
• Recalling Firm/ Manufacturer: Zimmer Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582-6989
• Manufacturer Reason for Recall: Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.
• FDA Determined Cause: Labeling False and Misleading
• Action: On June 5, 2017, Zimmer Biomet distributed Urgent Medical Device Recall notices to their customers via email and Fed Ex courier service. ***Risk Managers are advised to: 1. Review this notification and ensure affected personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative to quarantine all affected product. 3. Work with your Zimmer Biomet sales representative in removing the affected product from your facility. 4. Confirm that the patient labels in your records are correct. 5. Complete the  Certificate of Acknowledgement and return a digital copy to corporatequality.postmarket@zimmerbiomet.com and retain a copy of the Acknowledgement Form with your recall records in the event of a compliance audit of your facilities documentation. ****Distributors, Sales Reps & Distributor Operation Managers are advised to: 1. Review this notification and ensure affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1  Inventory Return Certification Form and return a digital copy to corporatequality.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. a. Request a Recall Return Authorization Number via SMS or via email to rgarequest@zimmerbiomet.com (domestic) or via email to zimmerbiometintlirarequests@zimmerbiomet.com (international). b. For each return, send a copy of Attachment 1 to corporatequality.postmarket@zimmerbiomet.com. c. Include a hardcopy of Attachment 1 with your shipment for immediate processing. d. Mark the outside of the returns box(es) clearly with RECALL. Customers with further questions or concerns please call the customer call center at 1-574-371-3071 between 8:00 am and 5
• Distribution: Nationwide in US; Internationally Argentina, Netherlands & 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 = KWT