Class 2 Device Recall Biomet OnPoint SCOPE PROCEDURE KIT

• Date Initiated by Firm: September 04, 2020
• Create Date: October 08, 2020
• Recall Status: Terminated on August 31, 2021
• Recall Number: Z-0082-2021
• Recall Event ID: 86424
• Product Classification: unknown device name - Product Code N/A
• Product: Biomet OnPoint SCOPE PROCEDURE KIT Item Number: 24-3050
• Code Information: Lot Numbers: 868570A 868670A 869650A 869710B 869770A 880720B 926610B 941910A 868570B 868670B 869650B 869720A 869770B 880730A 926620A 941910B 868590A 868680A 869660A 869720B 869780B 880730B 926620B 941920A 868610A 868680B 869660B 869730A 869790B 926570A 926630A 941920B 868610B 868690A 869680B 869730B 880610B 926570B 926630B 941930B 868640A 868690B 869690A 869740A 880700A 926580B 926640A 942010B 868650A 868700A 869690B 869740B 880710A 926590A 926640B 942030B 868650B 868700B 869700A 869750A 880710B 926600A 941900A 942040A 868660A 868710A 869700B 869750B 880720A 926610A 941900B 942040B 868660B 868710B 869710A 869760B
• FEI Number: 1825034
• Recalling Firm/ Manufacturer: Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582-6989
• For Additional Information Contact: 411 Technical Services; 574-371-3071
• Manufacturer Reason for Recall: Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
• FDA Determined Cause: Process change control
• Action: Zimmer Biomet notified on 9/2/20 Distributors with direct sales and/or fielded inventory via email and traceable letter sent via FedEx. Hospitals with direct sales or current inventory, as well as hospitals that have consumed products in the past 12 months will be notified via FedEx. Surgeons that have consumed products with in the past 12 months notified via FedEx. 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. Complete Attachment 1  Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form will be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. 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. 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. 3. Complete Attachment 1  Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you ha
• Quantity in Commerce: 80 units US
• Distribution: Nationwide Foreign: Canada, FINLAND, NETHERLANDS, UNITED KINGDOM

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.