For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
Summary
The FDA issued a Class II for For intraventricular indications mainly used for operations within the brain ven by Aesculap Implant Systems LLC. Reason: Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a result, when used with the 30¿ neuroendoscope, a port.
Details
Source
Device Recall
External ID
Z-2518-2023
Action Date
2023-09-13
Status
Ongoing
Category
device
Product Description
For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
Lot/Code Info: 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
Quantity Affected: 25 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.
Distribution
US Nationwide distribution in the states of FL, ID, IL, MD, NC, NY, OR, RI, TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-07-20
Company
Center Valley, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 148 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Aesculap Implant Systems LLC has 34 FDA actions in our database, including 33 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Aesculap Implant Systems LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Aesculap Implant Systems LLC have FDA actions?
Aesculap Implant Systems LLC has 34 FDA actions in our database, including 33 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2518-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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