Recall Z-2518-2023 ยท GWG Endoscope, Neurological
Aesculap Implant Systems LLC
For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
| Date | Sep 6, 2023 (initiated Jul 20, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process change control |
| 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 a |
| Quantity | 25 units |
| Distribution | US Nationwide distribution in the states of FL, ID, IL, MD, NC, NY, OR, RI, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983365 | AESCULAP MINOP SYSTEM Aesculap, Inc., Dec 18, 1998 |