Zimmer Biomet issued "URGENT MEDICAL DEVICE RECALL" Letter on 10/31/18 via email and FedEx to the consumer/user level, including any intermediate wholesale or retail consignees, distributors and Risk managers.
Distributors responsibilities include locating and removing the product in their territory, as well as identifying hospitals that have previously used the product. Hospital risk managers responsibilities include the following:
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 must 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].