FDA Medical Device Recalls (openFDA)
Aesculap Implant Systems LLC: For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
- Recall number
- Z-2518-2023
- Recalling firm
- Aesculap Implant Systems LLC
- Product
- For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
- Status
- Open, Classified
- Initiated
- 2023-07-20
- Posted
- 2023-09-06
- Terminated
- not on file
- 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 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.
- Quantity
- 25 units
- Distribution
- US Nationwide distribution in the states of FL, ID, IL, MD, NC, NY, OR, RI, TX.
- Lot, serial or model codes
- UDI-DI: 04038653065547 Lot Numbers: 52750146 52753381, 52756472, 52768317, 52805655, 52812596, 52816570, 52823878, 52830872. Serial Numbers: 4281,4282, 4284,4288, 4289,4291, 4308,4309, 4310, 4312, 4313,4336, 4340,4341, 4342,4402, 4411, 4412, 4413,4414, 4422,4439, 4447,4449, 4450
- 510(k) numbers
- ["K983365"]
- PMA numbers
- not on file
- Product code
- GWG
- Firm FEI
- 2916714
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28