For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
FDA device recall Z-2518-2023 · posted 2023-09-06 · Open, Classified
Recall details
- Recalling firm
- Aesculap Implant Systems LLC
- 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.
- Action taken
- 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 PA_QualityAssurance.BBMUS_Service@bbraunusa.com 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
- Status
- Open, Classified
- Product code
- GWG
- Quantity affected
- 25 units
- Distribution
- US Nationwide distribution in the states of FL, ID, IL, MD, NC, NY, OR, RI, TX.
- Date initiated
- 2023-07-20
- Date posted
- 2023-09-06
- Location
- Center Valley, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AESCULAP MINOP SYSTEM (K983365) | Aesculap, Inc. | 1998-12-18 |