For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
FDA Recall Z-2518-2023 · Posted 2023-09-06
Advertisement
Recalling FirmAesculap Implant Systems LLC
Recall StatusOpen, Classified
Product CodeGWG
Date Initiated2023-07-20
Product Quantity25 units
Reason for Recall
Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a result, when used with the 30 neuroendoscope, a portion of the visual field is obscured.
Firm Action
Aesculap issued Urgent Medical Device Recall Notification Letter via USPS Certified Mail 20.JUL.2023. Letter states reason for recall, health risk and action to take:
1. Review the Recall Notification in its entirety and ensure that all users in your
organization of the above-mentioned product, and all concerned persons are
informed about this voluntary product recall.
2. Your Aesculap Sales Representative will be in contact with you to review your
current inventory, aid in evaluating your devices and assist you in completing
the attached Product Acknowledgement Form.
3. Do not destroy any affected product.
4. Utilizing the attached form, you and your Sales Representative will record the
total number of individual impacted pieces. If you have no inventory
remaining, a zero (0) will be entered on the form.
5. Return the completed "Product Acknowledgement Form" to Aesculap, Inc.
Product Quality Excellence department by emailing the form to
[email protected] or faxing the form to
(610) 849-1197 after your inventory has been evaluated by your Sales
Representative, even if the total inventory in your possession is zero (0).
6. Once Aesculap, Inc. receives your "Product Acknowledgement Form", a
customer support representative will contact you with instructions on how to
return any impacted pieces in your possession.
Root Cause
Process change control
Distribution Pattern
US Nationwide distribution in the states of FL, ID, IL, MD, NC, NY, OR, RI, TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement