Recall Z-3212-2018

Reason for recall

The packaging sterile barrier does not comply with the applicable packaging standard for terminally sterilized medical devices. While the Instructions for Use (IFU) state Do not use if package has been previously opened or damaged , it is possible that the seal breach may go undetected by the user's naked eye.

FDA-determined cause: Under Investigation by firm

Action taken

Consignee Notification URGENT: MEDICAL DEVICE RECALL has been sent to US customers on 03-May-2018. For foreign customers, the Consignee Notification is in process. The Consignee letter informs customers of the situation and the required course of action which includes: 1. Cease use of the listed product 2. Account for number of product units used or discarded and return any units by completing the attached individualized Customer Confirmation form provided. Please follow the instructions described in the Customer Confirmation form. 3. Clinicians and their Patients who may have received the listed devices should monitor the patients condition to determine if there are any signs of infection. If this is the case, the patient should seek medical attention immediately to treat the infection. In addition, the Notification Letter should be provided to all those who need to be aware of this matter within your organization or to any organization where the potentially affected products may have been transferred. Fax the Customer Acknowledgement Response Form to Medtronic Neurosurgery at (805) 571-8787 or take a clear picture or scan of signed form and email it to rs.mnsfca@medtronic.com with "Magazine Recall" in the subject line.