Biomet ONPOINT SCOPE PROCEDURE KIT-EU Item Number: 24-3055
Recall
- Recall Number
- Z-0083-2021
- Event Number
- 86424
- Firm
- Biomet, Inc.
- FEI Number
- 1825034
- Product Code
- N/A
- Status
- Terminated
- Root Cause
- Process change control
- Initiated
- September 4, 2020
- Terminated
- August 31, 2021
- Address
- 56 E Bell Dr, Warsaw, IN, 46582-6989
Description
Biomet ONPOINT SCOPE PROCEDURE KIT-EU Item Number: 24-3055
Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
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 [email protected]. 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 [email protected]. 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 [email protected]. 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
Nationwide Foreign: Canada, FINLAND, NETHERLANDS, UNITED KINGDOM
US: 33 units; OUS: 269 units