Recall Z-2579-2021

Reason for recall

Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery

FDA-determined cause: Under Investigation by firm

Action taken

Aesculap issued An Urgent Medical Device Recall notification via USPS overnight to consignees on April 16, 2021. Letter states reason for recall, health risk and action to take: Immediately examine your inventory, identify and quarantine product related to this notification recall. In addition, if you have further distributed this product, please identify your customers and notify them at once of this Recall Notification. Your notification to your customers may be enhanced by including a copy of this notification letter. 1. Review the PAS-PORT Proximal Anastomosis System Recall Notification in its entirety and ensure that all users in your organization and other concerned persons are informed about this notification. 2. If you have further distributed this product, please identify and notify your customers of this action. We are requesting the product be returned. 3. Action is required of you to sign and return the provided Acknowledgement Response Form identifying (if applicable) the amount of product you have in your inventory. If you don t have any affected product, please enter zero in the space provided on the acknowledgement form. Please email to the address listed below before May 16, 2021. If the acknowledgement form has not been received at this time, another Recall Notification Letter will be sent. (Attachment 1 Medical Device Recall Notification Form). Send To: qa-recalls@aesculapusa.com 4. Identify your current inventory for the affected product. a. If you have identified inventory in your facility, DO NOT DESTROY any affected product. Contact Customer Service (info noted below) for an RGR number and return label to return your affected product. AIC Customer Service 1-800-282-9000 b. Once the RGR and return paperwork is provided, return a copy along with your affected product to the address listed below. Aesculap Inc. 615 Lambert Pointe Drive Hazelwood, MO 63042