Zimmer Biomet sent an Urgent Medical Device Recall letters to their affected customers. The letters identified the affected product, problem and the actions to be taken.
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. Immediately return all affected product from your distributorship and from affected hospitals within your territory.
a. For each return, complete Attachment 1 Inventory Return Certification Form and send to
[email protected] within three (3) days.
b. For each return, send a copy of Attachment 1 to
[email protected].
c. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing.
d. Mark RECALL on the outside of the returned cartons.
4. Return the Additional Accounts form to
[email protected].
a. Review the list of hospitals and/or surgeons included with the email notification sent to your facility, which includes a list of hospitals and/or surgeons that have already been notified of this recall.
b. Identify whether there are any additional hospitals and/or surgeons that Zimmer Biomet has not notified and list these accounts on the Additional Accounts form. Please provide the form in Excel format.
c. If there are no additional accounts or surgeons to notify, please indicate that there are no additional accounts, or indicate None or NA on the form.
5. Retain a copy of your Inventory Return Certification and product return forms for your records in the event of a compliance audit of your facility.
6. 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 transf