Class 2 Device Recall RINGLOC BIPOLAR

• Date Initiated by Firm: November 25, 2020
• Create Date: December 17, 2020
• Recall Status: Open, Classified
• Recall Number: Z-0628-2021
• Recall Event ID: 86896
• 510(K)Number: K051569
• Product Classification: Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate - Product Code MEH
• Product: RINGLOC BIPOLAR Hip System Bi Polar Locking Ring, Item number 11-165304 - Product Usage: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate, Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented, Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented.
• Code Information: Lot 173500
• Recalling Firm/ Manufacturer: Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582-6989
• For Additional Information Contact: 411 Technical Services; 574-372-3071
• Manufacturer Reason for Recall: Zimmer Biomet is conducting a lot specific medical device recall for multiple sterile Zimmer Biomet products due to the potential for a breach in the sterile seal. A breach in the packaging seal could potentially lead to loss of sterility of the device.
• FDA Determined Cause: Process control
• Action: On November 25, 2020, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were informed of the potential loss of sterility in affected devices. Customers were asked to do the following: Risk Manager Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. If the product has been further distributed, provide your customers with the field safety notice for hospitals and ensure documentation. Surgeon Responsibilities: 1. Review this notification for awareness of the contents. 2. There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule. All customers should also complete the certificate of acknowledgement included with the letter and return to the firm. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.
• Quantity in Commerce: 7428
• Distribution: Domestic distribution nationwide. Foreign distribution to ARGENTINA AUSTRALIA Brazil CANADA CHILE CHINA COSTA RICA EMEA HONG KONG INDIA JAPAN Japan KOREA MALAYSIA NEW ZEALAND SINGAPORE 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MEH and Original Applicant = BIOMET, INC.