Class 2 Device Recall Active Articulation ArComXL Polyethylene Bearings

• Date Initiated by Firm: December 19, 2016
• Create Date: January 13, 2017
• Recall Status: Terminated on September 19, 2017
• Recall Number: Z-1025-2017
• Recall Event ID: 75970
• 510(K)Number: K110555
• Product Classification: Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
• Product: Active Articulation ArComXL Polyethylene Bearings; Active Articulation ArComXL Bearings item XL-200152
• Code Information: Item XL-200152 Lot 339260 UDI (01)00880304491366(17)210713(10)339260
• Recalling Firm/ Manufacturer: Zimmer Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582-6989
• For Additional Information Contact: Customer Service; 800-348-2759
• Manufacturer Reason for Recall: Product complaints indicated that the part and lot numbers on the packaging differed from the physical product inside the packaging. Risk of delay in surgery.
• FDA Determined Cause: Under Investigation by firm
• Action: Zimmer Biomet sent an Urgent Medical Device Recall (REMOVAL)  LOT SPECIFIC notifications dated December 19, 2016, to the affected distributors and Risk Managers and Distributors 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 Manager Responsibilities: 1. Review this notification and ensure affected personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative quarantine all affected product. 3. Your Zimmer Biomet sales representative will remove the affected product from your facility. 4. Complete Attachment 1  Certificate of Acknowledgement. a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com. b. Retain a copy of the Acknowledgement Form with your recall 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 574-371-3071 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 corporatequality.postmarket@zimmerbiomet.com. Distributor Responsibilities 1. Review this notification and ensure that 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 a. 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
• Quantity in Commerce: 19
• Distribution: USA (nationwide) and Internationally to ARGENTINA
• 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 = LPH and Original Applicant = BIOMET MANUFACTURING CORP.